WO2009051682A1 - Devices, methods, and tools for effecting heart valve treatment - Google Patents

Abstract

Devices and methods for improving the function of a valve, such as, for example, a mitral valve.

Description

DEVICES, METHODS, AND TOOLS FOR EFFECTING HEART VALVE TREATMENT

CROSS-REFERENCE TO RELATED APPLICATION

[001] This patent application claims the benefits of priority under 35 U S C § 119 to U S Provisional Patent Application No 60/960,894, filed on October 18, 2007, entitled DEVICES, METHODS, AND TOOLS FOR EFFECTING HEART VALVE TREATMENT, the entirety of which is incorporated herein by reference

DESCRIPTION OF THE INVENTION

Field of the Invention

[002] Embodiments of the present invention relate to devices and associated methods for treating and improving the performance of heart valves More particularly, embodiments of the present invention relate to devices and methods that passively assist in improving the performance of a less than normally functioning heart valve

Background of the Invention

[003] Various etiologies may result in heart valve insufficiency depending upon both the particular valve as well as the underlying disease state of the patient For instance, a congenital defect may be present resulting in poor coaptation of the valve leaflets, such as in the case of a monocusp aortic valve Valve insufficiency also may result from an infection, such as rheumatic fever, for example, which may cause a degradation of the valve leaflets Functional regurgitation also may be present In such cases, the valve components may be normal pathologically, yet may be unable to function properly due to changes in the surrounding environment Examples of such changes include geometric alterations of one or more heart chambers and/or decreases in myocardial contractility In any case, the resultant volume overload that exists as a result of an insufficient valve may increase chamber wall stress Such an increase in stress may eventually result in a dilatory process that further exacerbates valve dysfunction and degrades cardiac efficiency [004] Mitral valve regurgitation often may be driven by the functional changes described above Alterations in the geometric relationship between valvular components may occur for numerous reasons, including events ranging from focal myocardial infarction to global ischemia of the myocardial tissue Idiopathic dilated cardiomyopathy also may drive the evolution of functional mitral regurgitation These disease states often lead to dilatation of the left ventricle Such dilatation may cause papillary muscle displacement and/or dilatation of the valve annulus As the papillary muscles move away from the valve annulus, the chordae connecting the muscles to the leaflets may become tethered Such tethering may restrict the leaflets from closing together, either symmetrically or asymmetrically, depending on the relative degree of displacement between the papillary muscles Moreover, as the annulus dilates in response to chamber enlargement and increased wall stress, increases in annular area and changes in annular shape may increase the degree of valve insufficiency Annular dilatation is typically concentrated on the posterior aspect, since this aspect is directly associated with the dilating left ventricular free wall and not directly attached to the fibrous skeleton of the heart Annular dilatation also may result in a flattening of the valve annulus from its normal saddle shape

[005] Alterations in functional capacity also may cause valve insufficiency In a normally functioning heart, the mitral valve annulus contracts during systole to assist in leaflet coaptation Reductions in annular contractility commonly observed in ischemic or idiopathic cardiomyopathy patients therefore hamper the closure of the valve Further, in a normal heart, the papillary muscles contract during the heart cycle to assist in maintaining proper valve function Reductions in or failure of the papillary muscle function also may contribute to valve regurgitation This may be caused by infarction at or near the papillary muscle, ischemia, or other causes, such as idiopathic dilated cardiomyopathy, for example

[006] The degree of valve regurgitation may vary, especially in the case of functional insufficiency In earlier stages of the disease, the valve may be able to compensate for geometric and/or functional changes in a resting state However, under higher loading resulting from an increase in output requirement, the valve may become incompetent. Such incompetence may only appear during intense exercise, or alternatively may be induced by far less of an exertion, such as walking up a flight of stairs, for example.

[007] Conventional techniques for managing mitral valve dysfunction include either surgical repair or replacement of the valve or medical management of the patient. Medical management typically applies only to early stages of mitral valve dysfunction, during which levels of regurgitation are relatively low. Such medical management tends to focus on volume reductions, such as diuresis, for example, or afterload reducers, such as vasodilators, for example.

[008] Early attempts to surgically treat mitral valve dysfunction focused on replacement technologies. In many of these cases, the importance of preserving the native subvalvular apparatus was not fully appreciated and many patients often acquired ventricular dysfunction or failure following the surgery. Though later experience was more successful, significant limitations to valve replacement still exist. For instance, in the case of mechanical prostheses, lifelong therapy with powerful anticoagulants may be required to mitigate the thromboembolic potential of these devices. In the case of biologically derived devices, in particular those used as mitral valve replacements, the long-term durability may be limited. Mineralization induced valve failure is common within ten years, even in younger patients. Thus, the use of such devices in younger patient groups is impractical.

[009] Another commonly employed repair technique involves the use of annuloplasty rings. These rings originally were used to stabilize a complex valve repair. Now, they are more often used alone to improve mitral valve function. An annuloplasty ring has a diameter that is less than the diameter of the enlarged valve annulus. The ring is placed in the valve annulus and the tissue of the annulus sewn or otherwise secured to the ring. This causes a reduction in the annular circumference and an increase in the leaflet coaptation area. Such rings, however, generally flatten the natural saddle shape of the valve and hinder the natural contractility of the valve annulus This may be true even when the rings have relatively high flexibility

[010] To further reduce the limitations of the therapies described above, purely surgical techniques for treating valve dysfunction have evolved Among these surgical techniques is the Alfieπ stitch or so-called bowtie repair In this surgery, a suture is placed substantially centrally across the valve orifice between the posterior and anterior leaflets to create leaflet apposition Another surgical technique includes plication of the posterior annular space to reduce the cross-sectional area of the valve annulus A limitation of each of these techniques is that they typically require opening the heart to gain direct access to the valve and the valve annulus This generally necessitates the use of cardiopulmonary bypass, which may introduce additional morbidity and mortality to the surgical procedures Additionally, for each of these procedures, it is very difficult, if not impossible, to evaluate the efficacy of the repair prior to the conclusion of the operation

[011] Due to these drawbacks, devising effective techniques that could improve valve function without the need for cardiopulmonary bypass and without requiring major remodeling of the valve may be advantageous In particular, passive techniques to change the shape of the heart chamber and/or associated valve and reduce regurgitation while maintaining substantially normal leaflet motion may be desirable Further, advantages may be obtained by a technique that reduces the overall time a patient is in surgery and under the influence of anesthesia It also may be desirable to provide a technique for treating valve insufficiency that reduces the risk of bleeding associated with anticoagulation requirements of cardiopulmonary bypass In addition, a technique that can be employed on a beating heart would allow the practitioner an opportunity to assess the efficacy of the treatment and potentially address any inadequacies without the need for additional bypass support Summary of the Invention

[012] In general, embodiments of the invention relate to implants, tools, and methods for treating heart conditions, including, for example, dilatation, valve incompetencies, including mitral valve leakage, and other similar heart failure conditions, that overcome some or all of the disadvantages associated with prior devices and methods of treatment As will be described, embodiments of the invention relate to the implant placed on the heart to treat such conditions, the implant including a mitral valve splint having a tension member and anterior and posterior anchoring members configured and placed to treat, for example, an incompetent mitral valve of a heart

[013] Embodiments of the invention further include tools for performing a medical procedure, and particularly the placement of a mitral valve splint on the heart The tools may include, for example, an anterior anchoring member delivery catheter and a posterior anchoring member delivery catheter, an anterior sighting catheter and a posterior sighting catheter, an anterior needle and a posterior needle, and a sizing instrument The tools may further include tools for accessing a pericardial space, including an introducer, an access needle, a guidewire, and an access sheath Additional tools useful for accessing a pericardial space, identifying desirable sites for the implant, delivering the implant, evaluating the therapeutic effect of the implant, and other steps in method, are discussed below

[014] Embodiments of the invention further include methods for treating a heart valve The methods may include the steps of accessing the pericardial space, identifying an implantation site on a heart, implanting a device on the heart, and sizing the device on the heart The method may includes a percutaneous subxiphoid approach Specific details of each of these method steps is described in detail below Brief Description of the Drawings

[015] Fig 1 A is a superior, short axis, cross-sectional view of a human heart during diastole, showing a mitral valve splint extending through the heart and aligned generally orthogonal to the arcuate opening of the mitral valve,

[016] Fig 1 B is a lateral, long axis, cross-sectional view of the human heart and an exemplary embodiment of a mitral valve splint of Fig 1A,

[017] Fig 1C is an anterior, long axis view of the human heart and an exemplary embodiment of a mitral valve splint of Fig 1A₁

[018] Fig 2A is a superior, short axis, cross-sectional view of a human heart showing an incompetent mitral valve during systole,

[019] Fig 2B is a superior, short axis, cross-sectional view of the human heart of Fig 2A showing the formerly incompetent mitral valve during systole corrected with an exemplary embodiment of a mitral valve splint, in accordance with the principles of this disclosure,

[020] Fig 2C is an illustration of an exemplary insert member, in accordance with the principles of the present disclosure,

[021] Figs 3A-3G illustrate various views of an exemplary anterior anchoring member, in accordance with the principles of this disclosure,

[022] Figs 4A-4F illustrate various views of an exemplary anterior anchoring member delivery catheter, in accordance with the principles of this disclosure,

[023] Figs 5A-5C illustrate various views of an exemplary posterior anchoring member, in accordance with the principles of this disclosure,

[024] Figs 6A-6D illustrate various views of an exemplary posterior anchoring member delivery catheter, in accordance with the principles of this disclosure,

[025] Figs 7-7A illustrate an exemplary introducer, in accordance with the principles of this disclosure,

[026] Figs 8A-8C illustrate an exemplary embodiment of a pericardial access needle, in accordance with the principles of the this disclosure, [027] Fig 9 illustrates an exemplary embodiment of a guidewire, in accordance with the principles of this disclosure,

[028] Figs 10A-10D illustrate components of an exemplary embodiment of an access sheath, in accordance with the principles of this disclosure,

[029] Fig 1 1 illustrates an exemplary embodiment of a catheter securement clip, in accordance with the principles of this disclosure,

[030] Figs 12A-12B illustrate an exemplary embodiment of a vacuum tubing set, in accordance with the principles of this disclosure,

[031] Fig 13 illustrates an exemplary embodiment of a vacuum tubing line, in accordance with the principles of this disclosure,

[032] Figs 14A-14B illustrate an exemplary embodiment of an intracardiac echo (ICE) delivery catheter, in accordance with the principles of this disclosure,

[033] Figs 15A-15E illustrate components of an exemplary embodiment of an anterior sighting catheter, in accordance with the principles of this disclosure,

[034] Figs 16A-16C illustrate components of an exemplary embodiment of a posterior sighting catheter, in accordance with the principles of this disclosure,

[035] Figs 17A-17B illustrate an exemplary embodiment of a posterior needle, in accordance with the principles of this disclosure,

[036] Fig 18 illustrates an exemplary embodiment of an anterior needle, in accordance with the principles of this disclosure,

[037] Figs 19A-19C illustrate components of an exemplary embodiment of a snare, in accordance with the principles of this disclosure,

[038] Fig 20 illustrates an exemplary embodiment of an anterior tension member protector, in accordance with the principles of this disclosure,

[039] Fig 21 illustrates an exemplary embodiment of sizing instrument, in accordance with the principles of this disclosure,

[040] Fig 22 illustrates an exemplary embodiment of cautery device, in accordance with the principles of this disclosure, and [041] Fig 23 illustrates an exemplary embodiment of cautery guide, in accordance with the principles of this disclosure

Detailed Description of the Invention

[042] The various aspects of the devices and methods described herein generally pertain to devices and methods for treating heart conditions, including, for example, dilatation, valve incompetencies, including mitral valve leakage, and other similar heart failure conditions Each disclosed device may operate passively in that, once placed in the heart, it does not require an active stimulus, either mechanical, electrical, or otherwise, to function Implanting one or more of the disclosed devices operates to assist in the apposition of heart valve leaflets to improve valve function

[043] In addition, these devices may either be placed in conjunction with other devices, or may themselves function to alter the shape or geometry of the heart, locally and/or globally, and thereby further increase the heart's efficiency That is, the heart experiences an increased pumping efficiency through an alteration in its shape or geometry and concomitant reduction in stress on the heart walls, and through an improvement in valve function

[044] However, the devices disclosed herein for improving valve function can be "stand-alone" devices, that is, they do not necessarily have to be used in conjunction with additional devices for changing the shape of a heart chamber or otherwise reducing heart wall stress It is also contemplated that a device for improving valve function may be placed relative to the heart without altering the shape of the chamber, and only altering the shape of the valve itself

[045] The devices and methods described herein offer numerous advantages over the existing treatment for various heart conditions, including valve incompetencies The devices are relatively easy to manufacture and use, and the surgical techniques and tools for implanting the devices do not require the invasive procedures of current surgical techniques For instance, the surgical technique does not require removing portions of the heart tissue, nor does it necessarily require opening the heart chamber or stopping the heart during operation. For these reasons, the surgical techniques for implanting the devices disclosed herein also are less risky to the patient than other techniques. The less invasive nature of these surgical techniques and tools may also allow for earlier intervention in patients with heart failure and/or valve incompetencies.

[046] Embodiments of the devices and methods described herein involve geometric reshaping of the heart and treating valve incompetencies. In certain aspects of the devices and methods described herein, substantially the entire chamber geometry is altered to return the heart to a more normal state of stress. Exemplary models of this geometric reshaping, which includes a reduction in radius of curvature of the chamber walls with ventricular splints, may be found in U.S. Pat. Nos. 5,961 ,440 and 6,050,936, the entire disclosures of these patents are incorporated herein by reference. Prior to reshaping the chamber geometry, the heart walls experience high stress due to a combination of both the relatively large increased diameter of the chamber and the thinning of the chamber wall. Filling pressures and systolic pressures are typically high as well, further increasing wall stress. Geometric reshaping reduces the stress in the walls of the heart chamber to increase the heart's pumping efficiency, as well as to stop further dilatation of the heart.

[047] Although the methods and devices are discussed hereinafter in connection with their use in the left ventricle and for the mitral valve of the heart, these methods and devices may be used in other chambers and for other valves of the heart for similar purposes. One of ordinary skill in the art would understand that the use of the devices and methods described herein also could be employed in other chambers and for other valves of the heart. The left ventricle and the mitral valve have been selected for illustrative purposes because a large number of the disorders occur in the left ventricle and in connection with the mitral valve.

[048] The following detailed description of exemplary embodiments of the present invention is made with reference to the drawings, in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[049] In addition, the following detailed description is supplemented with Appendix A attached to this specification. The complete disclosure of Appendix A is incorporated by reference herein.

[050] Description of Heart Valve Treatment Devices

[051] With reference to Figs. 1A-1 C, a human heart H is shown during diastole. The devices and methods described herein are discussed with reference to human heart H, but may also be applied to other animal hearts not specifically mentioned herein. A superior, short axis, cross-sectional view of heart H is shown in Fig. 1A, a lateral, long axis, cross-sectional view of heart H is shown in Fig. 1 B, and an anterior, long axis view of heart H is shown in Fig. 1C. In each of Figs 1A-1C, a medical device 10 consistent with the principles of this disclosure is shown secured to heart H. According to one embodiment of the present invention, medical device 10 may generally include an elongate tension member 12 secured to an anterior anchoring member 14 and a posterior anchoring member 16, as set forth in the document labeled Appendix A and attached hereto, the entire contents of which is incorporated herein by reference. Anterior and posterior anchoring members 14 and 16, respectively, may include any known, suitable anchoring members, such as, for example, anchor pads.

[052] For purposes of discussion and illustration only, several anatomical features of the human heart H are labeled herein as follows: left ventricle ("LV"), right ventricle ("RV"), left atrium ("LA"), ventricular septum ("VS"), right ventricular free wall ("RVFW"), left ventricular free wall ("LVFW"), atrioventricular groove ("AVG"), mitral valve ("MV"), tricuspid valve ("TV"), aortic valve ("AV"), pulmonary valve ("PV"), papillary muscle ("PM"), chordae tendeneae ("CT" or simply "chordae"), anterior leaflet ("AL"), anterior leaflet ("PL"), annulus ("AN"), ascending aorta ("AA"), coronary sinus ("CS"), right coronary artery ("RCA"), left anterior descending artery ("LAD"), and circumflex artery ("CFX"). [053] As illustrated in Figs 1A-1 B, embodiments of medical device 10 may be secured to heart H in such a manner that it may extend through heart H₁ substantially bisecting the projection of the opening of a heart valve, such as, for example, mitral valve MV These embodiments of medical device 10 also may be aligned generally orthogonal to the arcuate opening defined between the anterior leaflet AL and the posterior leaflet PL of the mitral valve MV As depicted in Fig 1 B₁ these embodiments of medical device 10 may extend across the left ventricle LV at an inferior angle from the superior aspect of the left ventricular free wall LVFW, through the ventricular septum VS, and across right ventricle RV near the intersection of the right ventricle RV and ventricular septum VS Those having ordinary skill in the art will readily appreciate that the orientations of medical device 10 described herein are for exemplary purposes only, and that medical device 10 may be secured to heart H in any of a number of desirable orientations

[054] With continuing reference to Fig 1 B, both anterior anchoring member 14 and posterior anchoring member 16 may be seated on an external surface of heart H, such as, for example, the epicardium of heart H₁ while the tension member 12 extends through, among other things, the myocardium and ventricular chamber(s) of heart H Such positioning may allow for medical device 10 to have both anchoring members 14 and 16 placed epicardially, so as to avoid the need for positioning a pad interior to any of the heart chambers To avoid interference with mitral valve MV function, anchoring members 14 and 16 may be positioned such that tension member 12 extends inferiorly of the leaflets AL and PL and chordae CT of the mitral valve MV

[055] To maximize shape change effects upon the mitral valve MV, and in particular the papillary muscles PM and/or annulus AN₁ the posterior anchoring member 16 may have a plurality of spaced contact zones, such as, for example, an inferior contact zone 20 and a superior contact zone 22, as discussed in greater detail below As depicted in Fig 1 B, inferior and superior contact zones 20 and 22 may be positioned on an epicardial surface of heart H proximate the papillary muscles PM and annulus AN, respectively In particular, the posterior anchoring member 16 may be positioned such that the superior contact zone 22 rests, for example, in, or proximate to, the atrioventricular groove AVG, which is located on an external surface of H that corresponds generally to the position of annulus AN of mitral valve MV In this position, the application of deforming forces brought about by the posterior anchoring member 16 causes a direct deformation of the annulus AN of the mitral valve MV, and/or repositioning of the papillary muscles PM Both of these actions contribute to improved coaptation of the leaflets AL and PL, which in turn may facilitate improving mitral valve function

[056] Still referring to Fig 1 B, the anterior anchoring member 14 may be positioned on the epicardial surface of the right ventricle RV, proximate of the right ventricular outflow track, and close to the intersection of the right ventricular free wall RVFW and the ventricular septum VS In this position, the impact of placing and/or adjusting medical device 10 upon the function of right ventricle RV may be limited Additionally, placing the anterior anchoring member 14 in this position may facilitate avoiding interference with critical blood vessels and/or conduction pathways For example, as shown in Fig 1C, the anterior anchoring member 14 may be so positioned to one side of the left anterior descending coronary artery LAD to avoid interference therewith

[057] The position of medical device 10, and its related components, shown in Figs 1A-1C, is understood to be exemplary Furthermore, medical device 10 may be positioned in virtually any desired orientation relative to the heart, depending on the particular heart at issue It is also contemplated that the medical device 10 may be utilized in conjunction with additional ventricular shape change devices such as, for example, those described in U S Pat No 6,261 ,222 to Schweich, Jr et al , and/or U S Patent No 6,183,411 to Mortier et al , the entire disclosures of which are incorporated herein by reference

[058] As alluded to above, embodiments of the disclosed medical device 10 may improve mitral valve function through a combination of effects First, the shape of annulus AN may be directly altered, preferably during the entire cardiac cycle (including diastole and systole), thereby reducing the annular cross-sectional area and bringing the posterior leaflet PL in closer apposition to the anterior leaflet AL Second, the position and rotational configuration of the papillary muscles PM and surrounding areas of the left ventricle LV may be altered further by the adjustment (e g , tightening) of tension in elongate tension member 12 Such adjustment places the chordae CT in a more favorable state of tension, allowing the leaflets AL and PL to more fully appose each other Third, since the annulus AN of the mitral valve MV is muscular in nature and actively contracts during systole, changing the shape of annulus AN will also reduce the radius of curvature of at least portions of annulus AN, just as the shape change induced by ventricular splints discussed hereinbefore reduces the radius of at least significant portions of the ventricle This shape change and radius reduction of the annulus AN causes off-loading of some of the wall stress on the annulus AN This, in turn, assists the annulus's ability to contract to a smaller size, thereby promoting better closure of the mitral valve MV during systole These effects are illustrated in Figs 2A- 2B

[059] In Fig 2A, there is depicted an incompetent mitral valve MV during the systolic phase of the cardiac cycle Mitral valve MV may be rendered incompetent by several different mechanisms, such as, for example, a dilated annulus AN and/or a displaced papillary muscle PM caused by ventricular dilation In Fig 2B, there is illustrated the formerly incompetent mitral valve MV of Fig 2A as corrected with medical device 10 Medical device 10 may facilitate correcting the incompetencies of mitral valve MV by causing an inward displacement of a specific portion of the left ventricular free wall LVFW, which may result in a reconfiguration and reshaping of annulus AN and/or papillary muscles PM, which then may result in the promotion of more complete closure of the mitral valve leaflets AL and PL

[060] As mentioned hereinbefore, the medical device 10 may generally include an elongate tension member 12 secured to an anterior anchoring member 14 and a posterior anchoring member 16 Members 14 and 16 may essentially function as epicardial anchors that engage the heart wall and provide surfaces adjacent the exterior of the heart wall to which the tension member 12 may be connected Additionally, while members 14 and 16 are not depicted as penetrating heart tissue, it is contemplated that embodiments of one or both of members 14 and 16 may indeed penetrate heart tissue, either completely or partially, so as to, for example, grip the heart wall

[061] Elongate tension member 12 may include a unitary or composite structure Exemplary embodiments of tension member 12 may include an inner cable (not shown) to provide mechanical integrity and an outer covering to provide biocompatibility The inner cable may include any known, suitable configuration and be made of any suitable material known to those of ordinary skill in the art By way of example, not limitation, the inner cable of tension member 12 may have a braided-cable construction such as, for example, a multifilar braided polymeric construction In general, the filaments forming the inner cable of tension member 12 may comprise, among other things, high performance fibers For example, the inner cable may comprise (braided or unbraided) filaments of ultra high molecular weight polyethylene available under the trade names SPECTRA™ and DYNEEMA™ Alternatively, it is contemplated that the inner cable may include filaments of other known, suitable materials, such as, for example, polyester available under the trade name DACRON™ or liquid crystal polymer available under the trade name VECTRAN™

[062] The filaments forming the inner cable of tension member 12 may be combined in yarn bundles of approximately 50 individual filaments, with each yarn bundle being approximately 180 denier For example, two such bundles may be paired together (commonly referred to as 2-ply) and then braided with approximately 16 bundle pairs to ultimately form the inner cable of tension member 12 The braided cable may include, for example, approximately 20-50 picks per inch (number of linear yarn overlaps per inch), such as approximately 30 picks per inch The inner cable may have an average diameter of approximately 0 030 to 0 080 inches, for example, or approximately 0 055 inches, with approximately 1600 individual filaments Further aspects of the inner cable of the elongate tension member 12 are described in U S Patent No 6,537,198, entitled A SPLINT ASSEMBLY FOR IMPROVING CARDIAC FUNCTION IN HEARTS, AND METHOD FOR IMPLANTING THE SPLINT ASSEMBLY (hereinafter referred to as the "'198 patent"), the entire disclosure of which is incorporated herein by reference

[063] When formed within the aforementioned parameters, for example, the inner cable may permit the tension member 12 to withstand the cyclical stresses within the heart chamber without breaking or weakening, provide a strong connection to anchoring members 14 and 16, minimize damage to internal vascular structure and heart tissue, and minimize the obstruction of blood flow within the heart chambers Although exemplary parameters for the inner cable of tension member 12 have been described above, other combinations of known, suitable material, yarn density, number of bundles, and pick count may be used, so as to achieve one or all of the desired characteristics noted above

[064] As mentioned above, the inner cable of tension member 12 may be surrounded by an outer covering, which may provide properties that facilitate sustained implantation in the heart H Specifically, because tension member 12 may be exposed to blood as it resides within a chamber of heart H, the outer covering may provide, among other things, resistance to thrombus formation Furthermore, because of the relative motion that occurs between the heart H and certain portions of tension member 12 passing through the heart chamber walls, the outer covering may be configured to allow for tissue ingrowth to establish a relatively firm bond between the tension member 12 and the portions of the heart wall through which tension member 12 passes Such tissue ingrowth may result in reducing the relative motion between tension member 12 and the heart wall and potential irritation of the heart

[065] The outer covering surrounding the inner cable of the tension member 12 may include any known, suitable configuration and be made of any suitable material known to those having ordinary skill in the art For example, the outer covering may include a removable sleeve made of porous expanded polytetrafluoroethylene (ePTFE) In some embodiments, the ePTFE material may be preferred because it is biostable and resists degradation and/or corrosion in the body [066] Additionally, since the tension member 12 may be advanced to a treatment site in a number of ways, such as, for example, by means of an imaging device, the outer covering may include radiopaque material and/or sonoreflective markers to facilitate fluoroscopic visualization during the implantation procedures. Furthermore, the outer covering may include one or more coatings, such as, for example, a hydrophilic coating configured to ease insertion of tension member 12 through the delivery/procedural devices discussed in greater detail below.

[067] The ePTFE sleeve may have a substantially cylindrical configuration with a lumen passing therethrough. For example, the ePTFE sleeve may have an inner diameter of approximately 0.040 inches and a wall thickness of approximately 0.005 inches, for example, prior to placement around the inner cable of the tension member 12. The sleeve may be secured over the inner cable of tension member 12 by any known, suitable method. For example, the inner diameter of the sleeve may stretch to fit around the inner cable to provide a frictional fit therebetween. Alternatively, or in addition, the sleeve may be secured to the inner cable with the aid of known, suitable adhesives.

[068] As alluded to above, the ePTFE material of the outer covering may be configured to promote tissue ingrowth. For example, the ePTFE material of the outer covering may have an intemodal distance of between approximately 20 and approximately 70 microns, such as, for example, approximately 45 microns. Such internodal distance configuration may serve to facilitate cellular infiltration, which in turn may result in secure ingrowth of the adjacent heart wall tissue so as to create a tissue surface on the tension member 12 residing in the heart chamber. The ePTFE material, particularly having the internodal spacing discussed above, may be preferred because it also possesses a high resistance to thrombus formation and is capable of withstanding the cyclic bending environment associated with a beating heart. Further aspects of the outer covering of the tension member 12 are described in the '198 patent noted above. Although ePTFE has been described as a suitable material for the outer covering of the tension member 12, other known, suitable materials exhibiting similar characteristics also may be used

[069] In some embodiments, tension member 12 may be provided with a removable cover (not shown) made of, for example, any suitable thermoplastic elastomer, such as, for example, the block copolymer commonly referred to as polyether block amide and available under the trade name PEBAX® The removable cover may be provided with materials, such as, for example, tungsten, to facilitate visualization of the tension member 12 during implantation procedures The removable cover may include a tungsten flat ribbon imbedded in a thin walled polymer tube Such an arrangement allows sufficient flexibility and visualization Furthermore, the removable cover may be provided with one or more coatings, such as, for example, a hydrophilic coating, configured to reduce or eliminate friction between the cover and delivery/procedural devices, so as to ease insertion of the tension member 12 through these devices and through the myocardium of heart H In some embodiments, the removable cover may be configured to be replaced over tension member 12 once removed, if, for example, the device 10 needs to be exchanged for a different size

[070] In order to facilitate delivery (e g , percutaneous delivery) of tension member 12 to an implantation site, a distal end of tension member 12 may be provided with a leader wire (not shown) The leader wire may have any suitable configuration to achieve the desired effect For example, leader wire may be approximately 63 inches in length, approximately 0 014 inches in diameter, and may be provided with a distal tip made of, for example, platinum The leader wire may be connected to tension member 12 by any suitable means For example, in some embodiments, the leader wire may be provided with a 0 25 inch stainless steel strain relief (not shown) that is swaged over the leader wire, in order to provide a means for attaching the leader wire to the tension member 12 Furthermore, some embodiments of tension member 12 may be provided with stainless steel band (not shown) that is swaged in place approximately two inches from the above-noted strain relief The stainless steel band may function as a "stop" that may facilitate attachment of the tension member sizing instrument discussed in greater detail below

[071] As noted above, the elongate tension member 12 is configured to be secured to anterior anchoring member 14 and posterior anchoring member 16 Although the illustrated embodiments depict that anterior and posterior anchoring members 14 and 16 may be secured to tension member 12 during implantation, at least one of anchoring members 14 and 16 may be fixed to tension member 12 prior to implantation to, for example, facilitate delivery of medical device 10

[072] To facilitate connection of tension member 12 to, for example, posterior anchoring member 16, a proximal end of tension member 12 may be provided with an insert 12a, as depicted in phantom in Fig 2C Insert 12a may be made of any suitable material, such as, for example, polyetheretherketone (PEEK) Furthermore, insert 12a may be configured to be secured to posterior anchoring member 16 by any suitable means, as will be discussed in greater detail below

[073] Insert 12a may be secured to a proximal end of tension member 12 by any suitable means For example, as shown in Fig 2C, insert 12a may be provided with a plurality of locking pins 12b for penetrating tension member 12 and securing it to insert 12a Locking pins 12b may have any suitable configuration and may be made of any suitable material to achieve the desired effect For example, locking pins 12b may be made from a nickel-cobalt-chromium-molybdenum alloy (MP35N)

[074] In some embodiments, insert 12a may be provided with one or more means of preventing tension member 12 from being advanced beyond the area that is readily accessible during the procedure For example, insert 12a may be of sufficient size to prevent passage of insert 12a into an access sheath Insert 12a may be removed prior to attachment of a posterior anchoring member delivery catheter Insert 12a may be provided with an 0-rιng (not shown) that may be sutured to a proximal side of the insert

[075] Turning to Figs 3A-3G, anterior anchoring member 14 may be any suitable anchoring member having any suitable configuration For example, as shown in Fig 3A, anterior anchoring member 14 may include an anchor pad having a substantially disc-shaped configuration Anchoring member 14 may also have any suitable shape, such as, for example, the elliptical shape depicted in Fig 3A Anchoring member 14 also may be made from any suitable material known in the art For example, anchoring member 14 may be made from a rigid thermoplastic, such as, for example, PEEK, polysulfone, polymethylpentene, or polyacetal The selected material should be machinable and, if desired, moldable Furthermore, anchoring member 14 should have any known, suitable dimensions For example, in embodiments where anchoring member 14 is selected to be of an elliptical shape, anchoring member 14 may have a major axis diameter of approximately 2 cm to 4 cm, a short axis diameter of approximately 1-3 cm, and a thickness of approximately 2 5 mm-10 mm

[076] Anterior anchoring member 14 may include one or more heart engaging surfaces 14', as shown for example in Figure 3E Heart engaging surface 14' may include any known, suitable configuration and/or shape, and may be configured to match the contour of the epicardium of heart H For example, surface 14' may be slightly convex in nature, since providing a smooth, rounded surface adjacent a heart wall facilitates reducing localized compressive pressures that may otherwise be exerted on the heart wall Such reduction in localized compressive pressures may reduce the risk of necrosis of heart tissue, which ultimately could lead to anchoring member 14 migrating through the thickness of the heart wall

[077] Furthermore, the heart engaging surface 14' may be provided with an anchoring mechanism The anchoring mechanism may include any known, suitable mechanism that facilitates securing the heart engaging surface 14' to heart H For example, the mechanism may include a fabric covering that facilitates ingrowth of heart wall tissue to secure anchoring member 14 to the epicardium of heart H and thereby prevent long-term, motion-induced irritation thereto The covering may be made of any suitable material known to those of ordinary skill in the art For example, the covering may be made of a velour woven polyester material, such as that commonly available under the trade name of DACRON™ In some embodiments, it may be preferred to fabricate the covering from ePTFE The covering may be secured to the PEEK body of anchoring member 14 by any known, suitable method known to those of ordinary skill in the art For example, the pad covering may be sewn to the PEEK with a number of polyester sutures

[078] The side of anchoring member 14 opposite heart engaging surface 14' includes a plurality of non-heart engaging surfaces 15a-15e Fabric may cover none, some, or all of surfaces 15a-15e

[079] To facilitate visualization of anchoring member 14 during, for example, implantation, anchoring member 14 may be provided with one or more radiopaque and/or sonoreflective markers (not shown) These markers may be provided on any suitable location of anchoring member 14, and may be provided by any suitable means known to those of ordinary skill in the art For example, a platinum/indium coil may be threaded over a portion of the sutures that are used to secure the above-mentioned covering to the PEEK body of member 14

[080] To facilitate delivery, such as, for example, percutaneous delivery, of anchoring member 14 to heart H, embodiments of member 14 may be configured to move between an expanded configuration, depicted in Figs 3A, and a collapsed configuration, depicted in Fig 3B As will be discussed below in greater detail below, anchoring member 14 may be provided in a collapsed configuration to facilitate, for example, passage through a delivery catheter, specifically access sheath 1010 shown in Figure 10B Once delivered to heart H, anchoring member 14 may then be manipulated in the expanded configuration, to increase the surface area with which it contacts heart H

[081] Turning to Fig 3C, there is illustrated an exploded view of anterior anchoring member 14 Anchoring member 14 may include, among other things, a core 17 Core 17 may include any suitable configuration or shape For example, as depicted, core 17 may include a substantially elongated configuration Core 17 may include a base 17a that may serve as the central support structure of anchoring member 14 Base 17a may have one or more recessed areas 17b for connection to a wing 19, as discussed below in greater detail Base 17a may also include a first raised portion 17c Raised portion 17c may be generally semi-circular in configuration As depicted in Fig 3D, raised portion 17c may include a substantially flat internal surface 17d and a substantially curved external surface 17e, which may define an outer periphery of anchoring member 14 Raised portion 17c may also include first and second through holes 17f and 17f"

[082] With reference to Figs 3C and 3F-3G, base 17a may include a second raised portion 17g spaced away from first raised portion 17c by a gap 17h Raised portion 17g may include any suitable configuration For example, raised portion 17g may include a substantially rectangular configuration, having a top surface 17ι, and at least one side surface 17j Top surface 17ι may include a through hole 17q for receiving a portion of tension member 12, as will be discussed in greater detail below Through hole 17q may be generally located at the geometric center of anchoring member 14 and have any suitable shape and configuration For example, through hole 17q may be substantially circular and have a tapered opening on top surface 17ι The tapered opening may decrease the amount of localized stresses exerted on tension member 12 by the edges of through hole 17q

[083] Side surface 17j may include a first opening 17k Opening 17k may have any suitable configuration and shape For example, as depicted, opening 17k may be substantially circular in shape and tapered Opening 17k may lead to a first channel 17r, depicted in Figs 3F-3G, that may extend into raised portion 17g The first channel may be configured to receive alignment pin 21 , which will be discussed below in greater detail For example, the first channel may have a smaller diameter than alignment pin 21 so as to create a press fit connection between the channel and alignment pin 21 Alternatively, alignment pin 21 may be secured with the channel by any suitable means known to those of ordinary skill in the art

[084] Side surface 17j may also include a second opening 171 Like opening 17k, opening 171 may have any suitable configuration and shape For example, opening 171 also may be substantially circular in shape and tapered Opening 171 may lead to a second channel 17s, depicted in Figs 3F and 3G, that may extend, preferably parallel to the first channel, into raised portion 17g The second channel 17s may be configured to receive forward stop pin 25, which will be discussed below in greater detail For example, the second channel 17s may have a smaller diameter than forward stop pin 25 so as to create a press fit connection between the channel 17s and forward stop pin 25 Alternatively, stop pin 25 may be secured with the channel by any suitable means known to those of ordinary skill in the art In particular, it is contemplated that embodiments of core 17 may include threads (not shown) within the second channel and corresponding mating threads on forward stop pin 25

[085] Raised portion 17g may have a pair of parallel legs 17m and 17n extending therefrom, as depicted in Fig 3C Legs 17m and 17n may be spaced from each other by a recess 17o Recess 17o may extend into raised portion 17g of core 17, as in Figs 3F and 3G As will be discussed in greater detail below, recess 17o may house, among other things, over-snap pin 22, staple 23, and pull cylinder 24

[086] Leg 17n may include an opening 17p Like openings 17k and 171, opening 17p may also have any suitable configuration and shape known to those of ordinary skill in the art For example, opening 17p may be substantially oval in shape and tapered Opening 17p may lead to a third channel 17t that may extend, preferably at an acute angle to the first and second channels, into leg 17n and raised portion 17g Each of legs 17m and 17n may terminate in a flared portion having a substantially curved external surface, which, like surface 17e, may serve to define a periphery of anchoring member 14 Surface 15b and 15c may extend from the flared portions of legs 17m and 17n, respectively

[087] Anchoring member 14 may further include a yoke 18 Yoke 18 may have any suitable configuration For example, yoke 18 may include a substantially rectangular body portion 18a having two legs 18b and 18c extending therefrom Legs 18b and 18c may be spaced apart from each other by a recess 18d Yoke 18 may be slidably disposed relative to core 17, such that body portion 18a of yoke 18 may be received in gap 17h, and legs 18b and 18c may straddle raised portion 17g, as best depicted in Fig 3A Yoke 18 may be configured to slide between a first position depicted in Fig 3F and a second position depicted in Fig 3G

[088] Body portion 18a may include an opening 18f in communication with first through hole 17f of core 17 Opening 18f may have any suitable configuration and shape For example, opening 18f may be substantially circular in shape and may include a plurality of threads disposed therein Furthermore, opening 18f may be configured to allow an operator to slide yoke 18 relative to core 17

[089] Legs 18b and 18c may each include an actuation projection 18h configured to engage with a geometric configuration 19g on wings 19, to facilitate rotational movement of wings 19, as discussed in greater detail below Actuation projection 18h may have any suitable configuration For example, each actuation projection 18h may extend from surfaces of legs 18b and 18c Alternatively, actuation projection 18h may be a corner of legs 18b and 18c Furthermore, leg 18c may include an opening 18e configured to be aligned with opening 17k on raised portion 17g, when yoke 18 has been moved to the second position Opening 18e may have any suitable shape and configuration For example, opening 18e may have a substantially circular shape and may be tapered Opening 18e may be lead to a channel 18h that may extend into leg 18c of yoke 18 The channel may be configured to securely receive alignment pin 18g, which will be discussed below in greater detail For example, the channel may have a smaller diameter than alignment pin 18g so as to create a press fit connection between the channel and alignment pin 18g Alternatively, alignment pin 18g may be secured within the channel by any suitable means known to those of ordinary skill in the art

[090] Anchoring member 14 may also include a number of wings 19 Although the depicted embodiment of anchoring member 14 includes two wings 19, it is contemplated that anchoring member 14 may include a greater or lesser number of wings 19 as desired As shown in Fig 3A, wings 19 may include surfaces 15a and 15d Although each of heart engaging surfaces 15a and 15d are depicted as a continuous surface, each surface 15a and 15d may include a plurality of discrete surfaces Wings 19 may have any suitable shape and/or configuration For example, as depicted in Fig 3C, wings 19 may include a substantially curved flat internal side 19a and a substantially curved external side 19b Wings 19 may be configured to be rotatably connected to core 17, so that wings 19 may rotate between a first, closed position, depicted in Fig 3B, and a second, open position, depicted in Fig 3A

[091] To facilitate connection to core 17, each of wings 19 may include a hinge 19c projecting from internal side 19a Hinge 19c may be any suitable hinge Additionally, hinge 19c may include any suitable, appropriate shape, size and/or configuration For example, hinge 19c may be sized and configured to be received in recessed area 17b Hinge 19c may include an opening 19d for receiving a hinge pin 20, which may be used to rotatably mount wings 19 to core 17 Opening 19d may be any suitable configuration and may lead to a channel 19e within which hinge pin 20 may reside

[092] To facilitate rotation of wings 19, each wing 19 may include one or more geometric configurations 19g disposed on internal side 19a Geometric configurations 19g may include any suitable shape, size, and configuration For example, geometric configurations 19g may include projections configured for engagement with actuation projection 18h, as yoke 18 slides between the above described first and second positions

[093] To further facilitate visualization of anchoring member 14, and, in particular, to facilitate visualization and monitoring of wings 19 during expansion of anchoring member 14, wings 19 may include one or more radiopaque and/or sonoreflective markers These markers may be provided on any suitable location of wings 19, and may be provided by any suitable means known to those of ordinary skill in the art For example, an external periphery of wings 19 may include wing indicators 19f that may be visible with the aid of appropriate imaging means known in the art

[094] Turning now to Figs 4A-4E, there is depicted an embodiment of an exemplary delivery catheter 30 for anterior anchoring member 14 As shown in Fig 4A, anterior anchoring member 14 may be attached to a distal end 31 of delivery catheter 30 Distal end 31 may be connected to a proximal end 32 of delivery catheter 30 by a catheter shaft 33 Delivery catheter 30 may be utilized to, among other things, guide anchoring member 14 into position and expand it to its final configuration

[095] As shown in Fig 4B, catheter shaft 33 may include a main lumen 34 and two auxiliary lumens 36 and 46 Although the depicted embodiment of delivery catheter 30 includes three lumens, delivery catheter 30 may include a greater or lesser number of lumens Furthermore, delivery catheter 30 may include any suitable arrangement of lumens 34, 36, and 46 For example, lumens 34, 36, 46, may be disposed in the side- by-sιde arrangement depicted in Fig 4B However, any suitable arrangement of lumens 34, 36, and 46 is included within the principles of this disclosure Each of lumens 34, 36, and 46 may extend the entire length of catheter 30 (ι e , from distal end 31 to proximal end 32) or any portion thereof Furthermore, each lumen 34, 36, and 46 may include any configuration and shape known to those of ordinary skill in the art For example, each lumen 34, 36, and 46 may have a substantially circular cross section

[096] In the exemplary embodiment, main lumen 34 may be a lumen of tube 34a made from any suitable material known in the art, such as, for example, the PEBAX material referred to above However, any suitable known material may be utilized in the fabrication of main lumen tube 34a Main lumen tube 34a may also include one or more reinforcement mechanisms known to those of ordinary skill in the art For example, in the exemplary embodiment, the main lumen PEBAX® tube 34a may be reinforced with a stainless steel braid

[097] Main lumen tube 34a may include a single, continuous tube or a tube comprised of varying cross-sectional configurations, sizes, layers, and/or materials For example, the distal end of main lumen tube 34a may include a distal segment 34b Distal segment 34b either may be made of the same materials as the remainder of tube 34a or a differing material For example, distal segment 34b may also be made from PEBAX® Furthermore, the material utilized in fabricating distal segment 34b may have a hardness factor that is essentially similar or substantially different from the hardness factor of the remainder of tube 34a For example, it is contemplated that distal segment 34b may be made from PEBAX® having a shore hardness factor of 25D

[098] Distal segment 34b may be any suitable size and/or configuration However, in the exemplary embodiment discussed herein, it is contemplated that distal segment 34b may have a substantially cylindrical configuration, with a substantially circular cross-sectional area In the exemplary embodiment, distal segment 34b may be approximately one (1 ) inch in length and have an internal diameter of approximately 0 125 inches and an outside diameter of approximately 0 220 inches

[099] Turning now to Fig 4C, mam lumen 34 may include a number of components that operably connect delivery catheter 30 to anterior anchoring member 14 These components may include, but are not limited to, a release shaft 39 Release shaft 39 may essentially include any suitable shaft known to those of ordinary skill in the art, and may serve to release anchoring member 14 from delivery catheter 30 In the disclosed embodiment, a distal portion of release shaft 39 may be provided with screw threads 39b, facilitating attachment to anterior anchoring member 14 Any suitable means of securing release shaft 39 to anchoring member 14 may be utilized In the disclosed exemplary embodiment, threads 39b may be mated with corresponding threads provided within opening 17f Release shaft 39 may be made from any suitable material, such as, for example, stainless steel Furthermore, release shaft 39 may be slidably disposed within main lumen 34 In the depicted embodiment, release shaft 39 may include a lumen 39a, which may contain a wing control shaft 40 Wing control shaft 40 may be slidably disposed in lumen 39a, and may extend beyond a distalmost end of release shaft 39 Wing control shaft 40 may include any suitable shaft, and may serve to control the expansion of wings 19 Additionally, wing control shaft 40 may be made from any suitable material known to those of ordinary skill in the art For example, wing control shaft 40 may be made from stainless steel

[0100] As shown in Fig 4C, a distal region of wing control shaft 40 may be provided with a substantially cylindrical cap 40a Cap 40a may be provided with a cylindrical distal end 40a', which may include a diameter that is larger than lumen 39a, so as to prevent wing control shaft 40 from being completely withdrawn into lumen 39a Furthermore, an external surface of end 40a' may be provided with a means 40a" of securing cap 40a to yoke 18 While such means may include threads for mating with corresponding threads 18f provided within opening 18f in yoke 18, means 40a" may include any suitable means known in the art In the depicted embodiment, wing control shaft 40 may include a lumen 40b, which may contain a staple deployment pull-wire 41 therein

[0101] Pull-wire 41 may be slidably disposed within lumen 40b, and may be configured to extend beyond a distalmost end of cap 40a Pull-wire 41 may include any suitable pull-wire configuration A distal end of pull-wire 41 may include a pull-cylinder 42 adapted to engage portions of anchoring member 14, as will be discussed in greater detail below Pull-cylinder 42 may include any suitable geometric configuration known to those of ordinary skill in the art For example, geometric configuration 42 may include a cylinder, as depicted in Fig 4C

[0102] Although each of release core shaft 39, wing control shaft 40, and pull- wire 41 are depicted as including a substantially circular cross-sectional area, any suitable configuration may be employed in the design and fabrication of these components For example, one or all of release core shaft 39, wing control shaft 40, and staple deployment pull-wire 41 may include a substantially rectangular cross sectional area Furthermore, each of release shaft 39, wing control shaft 40, and pull- wire 41 may be configured to be rotatable relative to one another As will be discussed below in greater detail, the proximal ends of release shaft 39, wing control shaft 40, and pull-wire 41 , collectively or individually, may be operably coupled to an actuator 48

[0103] Distal end segment 34b of certain embodiments of main lumen tube 34a may be made of a differing material having differing properties than the material of the remainder of tube 34a, it is contemplated that the PEBAX® material used for distal segment 34b may be of a differing hardness than the remainder of main lumen tube 34a However, the distal end segment 34b of certain embodiments of main lumen tube 34a may be made of the same material and/or hardness as the remainder of mam lumen tube 34a

[0104] With continuing reference to Fig 4C, the distal end 34c of distal segment 34b may be connected to a steering collar 35 Steering collar 35 may include any suitable configuration For example, steering collar 35 may include two separable halves 35a and 35b that may be secured about distal end 34c in any conventional manner In the depicted exemplary embodiment, steering collar 35 may be secured to distal end 34c by clamping halves 35a and 35b about distal end 34c The separable halves 35a and 35b may be secured to each other by any known, suitable means For example, halves 35a and 35b may be secured to each other by means of conventional fasteners, such as, for example, screws 36

[0105] In certain embodiments, it is contemplated that steering collar 35 may be secured to distal end 34c with the aid of a lumen connector 37 Lumen connector 37 may have any suitable configuration and may be made of any suitable material For example, lumen connector 37 may comprise a substantially cylindrical shape and be made of stainless steel Lumen connector 37 may be secured to the distal end 34c by any suitable means known to those of ordinary skill in the art For example, lumen connector 37 may be stabilized with blue 25D PEBAX® reflowed over the lumen connector 37 and the distal end 34c

[0106] Steering collar 35 may further include a through lumen 38 Through lumen 38 may include any suitable configuration and/or shape For example, in the depicted embodiment, through lumen 38 includes a substantially cylindrical shape and a substantially circular cross sectional area Through lumen 38 may be configured to allow pad release core shaft 39, along with wing control shaft 40 and pull-wire 41 , access to anterior anchoring member 14, as will be discussed in greater detail below For example, through lumen 38 may be positioned so that it aligns with through hole 17f on core 17 and opening 18f on yoke 18

[0107] Steering collar 35 may further include one or more geometric configurations 43, which may facilitate the alignment of through lumen 38 with through hole 17f Geometric configuration 43 may include any suitable geometric configuration known to those having ordinary skill in the art For example, geometric configuration 43 may include a substantially cylindrically shaped projection that is configured to mate with second through hole 17f ' on core 17 Geometric configuration 43 may be spaced apart from through lumen 38 by the same distance that first through hole 17f is spaced from second through hole 17f\ so that insertion of geometric configuration into second through hole 17f may provide a tactile indication to an operator of the alignment of first through hole 17f and through lumen 38 Alternatively, it is contemplated that geometric configuration 43 may include a recess (not shown) configured to mate with a corresponding projection (not shown) provided on core 17, in order to provide a similar tactile indicator

[0108] With renewed references to Fig 4B, auxiliary lumens 36 and 46 may be lumens of tubes 36a and 46a, respectively Tubes 36a and 46a, and consequently, lumens 36 and 46, may have any suitable length For example, each of tubes 36a and 46a may be approximately 20 inches in length Additionally, tubes 36a and 46a may be made from any suitable, desired material For example, tubes 36a and 46a may also be made from PEEK While tubes 36a and 46a in the disclosed embodiment may be made from the same or substantially similar material, each of tubes 36a and 46a may be made from completely differing materials having similar or differing properties, as desired

[0109] As alluded to above, tubes 36a and 46a may have any suitable configuration known to those of ordinary skill in the art For example, tubes 36a and 46a may have substantially cylindrical shapes and a substantially circular cross sectional area Tubes 36a and 46a may also have any suitable dimensions For example, each of tubes 36a may have an inner diameter of approximately 0 039 inches and an outer diameter of approximately 0 052 inches Although tubes 36a and 46a in the discussed embodiment have similar dimensions and geometric configurations, tubes 36a and 46a may differ from each other in any of a number of ways, including dimensions and configuration [0110] Tubes 36a and 46a may extend along main tube 34a to distal end segment 34b and may be secured to main tube 34a by any suitable means known to those of ordinary skill in the art For example, tubes 36a and 46a may be secured to tube 34a with end cap 44, as shown in Fig 4C End cap 44 may have any suitable configuration For example, end cap 44 may have a generally ellipsoid shape and may be provided with three openings 44a-c, which accommodate tubes 34a, 36a, and 46a as shown Furthermore, end cap 44 may be made from any suitable biocompatible material For example, end cap 44 may be made from PEEK End cap 44 may be secured to tubes 34a, 36a, and 46a by any suitable means known in the art, including welding, sonic welding, adhesion, and/or friction In the exemplary embodiment discussed herein, end cap 44 may be press-fit over tubes 34a, 36a, and 46a

[0111] As shown in Fig 4B, tubes 34a, 36a, and 46a may be further secured together by any suitable means available to those having ordinary skill in the art For example, a Fluorinated Ethylene-Propylene (FEP) heat shrink wrap 47 may be provided over the three tubes 34a, 36a, and 46a over delivery catheter 30

[0112] With renewed reference to Fig 4A, the proximal end of main lumen tube 34a may include a proximal segment 34d Proximal segment 34d may be made of the same material as distal segment 34b, the remainder of tube 34a, or of a different material altogether For example, proximal segment 34d may be made of a dual layered tube having an outer layer made from PEBAX® having a shore hardness factor of 7OD, and an inner layer made from PEBAX® having a shore hardness factor of 63D A greater or lesser number of layers may be used, the shore hardness of each layer may be varied as desired, and any of the layers may be made from suitable materials other than PEBAX®

[0113] Proximal segment 34d may be any suitable size and/or configuration appreciated by those having skill in the art However, in the exemplary embodiment discussed herein, it is contemplated that proximal segment 34d may have a substantially cylindrical configuration, with a substantially circular cross-sectional area In the exemplary embodiment, proximal segment 34d may be approximately 20 inches long and have the same internal and outside diameters as distal segment 34b

[01 14] Turning now to Fig 4D, the proximal ends of tubes 34a, 36a, and 46a may be secured to an actuator The actuator may include any suitable actuator, such as, for example, handle 48 Handle 48 may include any suitable configuration, shape, and size For example, handle 48 may include a generally elongated shape, and may be configured to be comfortably operated with one hand As shown in Fig 4D, handle 48 may include a number of control mechanisms, including, but not limited to, steering mechanism 50, release mechanism 52, wing control mechanism 54, and staple deployment mechanism 56 Each of steering mechanism 50, release mechanism 52, wing control mechanism 54, and staple deployment mechanism 56 may be disposed within a handle housing 51 Housing 51 may include, among other things, a plurality of openings 51a-c for accommodating mechanisms 50, 52, and 54

[0115] Steering mechanism 50 may include any suitable mechanism known to those of ordinary skill in the art, and may be used to orient distal end 31 of delivery catheter 30, and anterior anchoring member 14, to an appropriate implantation position Steering mechanism 50 may be configured to move all or a portion of distal end 31 in any of a number of desired directions For example, as shown in Fig 4E, steering mechanism 50 may be configured to rotate distal end 31 by approximately 90 degrees Although the disclosed embodiment is depicted as being able to rotate in only one direction, those having ordinary skill in the art will recognize that steering mechanism 50 may rotate distal end 31 in any desired direction In certain embodiments, it is contemplated that steering mechanism 50 may also be configured to extend and/or retract distal end 31

[0116] Steering mechanism 50 may include a lever 50a rotatably disposed within housing 51 of handle 48 Lever 50a may be accessible to an operator through opening 51a in housing 51 Furthermore, lever 50a may include any configuration conducive to facilitating rotation of lever 50a For example, lever 50a may include a projection 50b configured to be actuated by an operator's thumb Lever 50a may be operably connected to the distal end 31 of delivery catheter 30 by a cable 58 Cable 58 may include any suitable cable known to those of ordinary skill in the art For example, cable 58 may include a polyethylene cable Cable 58 may be operably connected to lever 50a by any suitable means known in the art For example, cable 58 may be pinned to lever 50a within housing 51

[0117] With reference to Figs 4C-4F, cable 58 may extend to distal end 31 through one of tubes 36a and 46a, extend out of end cap 44, and into steering collar 35 Cable 58 then may be threaded through steering collar 35 so that cable 58 may return to handle 48 through the other of tubes 36a and 46a Cable 58 may be secured to steering collar 35 in any of a number of suitable ways For example, cable 58 may be secured to steering collar 35 by a knot 58a Knot 58a may be configured to prevent cable 58 from becoming separated from steering collar 35

[0118] As alluded to above, movement of lever 50a may result in movement, for example, rotational movement, of distal end 31 of delivery catheter 30 Therefore, in order to communicate a position of distal end 31 to an operator, housing 51 may be provided with an indicator 51d, as shown in Fig 4D Indicator 51d may include any suitable indicator known in the art, including, but not limited to, alpha-numeric characters, graphic designs, colors, and/or tactile configurations For example, in the disclosed embodiment, housing 51 may be marked with a "0" that indicates to an operator that distal end 31 is in a straight line with delivery catheter 30 Although the disclosed embodiment includes only one indicator 51d, those having ordinary skill in the art will readily recognize that housing 51 may be provided with any number of indicators

[01 19] Release mechanism 52 may include any suitable mechanism, and may be used to disengage anchoring member 14 from delivery catheter 30 In the disclosed embodiment, release mechanism 52 may include a substantially circular wheel 52a Wheel 52a may be accessible by an operator through opening 51b in housing 51 Furthermore, wheel 52a may be secured to a proximal end of release shaft 39, such that rotation, for example, counter-clockwise rotation, unscrews release shaft 39 from the opening 17f of core 17, thereby releasing anchoring member 14 from delivery catheter 30

[0120] Wing control mechanism 54 may include any suitable mechanism, and may be used to deploy (e g , expand) wings 19 of anterior anchoring member 14 In the disclosed embodiment, wing control mechanism 54 may include a substantially circular wheel 54a accessible by an operator through opening 51c in housing 51 Wheel 54a may be secured to wing control shaft 40 by any suitable means known to those of ordinary skill in the art For example, wheel 54a may be clamped and/or secured with fasteners, such as, for example, screws, to wing control shaft 40a Wheel 54a may be configured for longitudinal movement within opening 51c, such that advancing wheel 54a distally may result in corresponding movement of wing control shaft 40, which in turn may result in sliding yoke 18 distally, since wing control shaft 40 may be coupled directly to yoke 18 As noted above, moving yoke 18 may result in expansion of wings 19 Wheel 54a may also be configured for rotational movement, such that, once expansion of wings 19 has been effected, wheel 54a may be rotated, for example, in the counter-clockwise direction, to unscrew distal end 40a' from yoke 18

[0121] Staple deployment mechanism 56 may include any suitable mechanism known in the art, and may be used to deploy staple 23 through tension member 12

[0122] With reference now to Figs 5A-5C, there is depicted a posterior anchoring member 16 of medical device 10 Posterior anchoring member 16 may have any suitable configuration to achieve the desired effect In some embodiments, posterior anchoring member 16 may define one, two, or more heart engaging surfaces For, example posterior anchoring member 16 may define a superior contact zone 16a and an inferior contact zone 16b connected therebetween by a bridge 16c The superior contact zone 16a may rest on or adjacent the epicardial surface of the left ventricle LV, adjacent, for example, the annulus AN of the mitral valve MV associated with the posterior leaflet PL The inferior contact zone 16b may rest on the epicardial surface, for example, near the level of the papillary muscles PM of the mitral valve MV, positioned, for example, mid-way between the papillary muscles PM Furthermore, contact zones 16a and 16b may have any suitable configuration known in the art For example, as depicted in Fig 5A, zones 16a and 16b may have a substantially "D" shaped configuration In some embodiments, contact zones 16a and 16b may be provided with substantially convex configurations for engaging the epicardial surface of the left ventricle LV

[0123] Posterior anchoring member 16 may be made from any suitable material to achieve the desired effect For example, posterior anchoring member 16 may be from the same PEEK material as anterior anchoring member 14 Furthermore, posterior anchoring member 16 may include one or more suitable coverings and/or coatings on the portions of anchoring member 16 that contact surfaces of the heart, such as, for example, zones 16a and 16b In some embodiments, zones 16a and 16b may be provided with a polyester covering 16d Polyester covering 16d may be configured to, among other things, promote tissue ingrowth Additionally, polyester covering 16d may be secured to zones 16a and 16b by any suitable means For example, polyester covering may be sutured to zones 16a and 16b

[0124] To facilitate visualization of anchoring member 16 during, for example, implantation, anchoring member 16 may be provided with one or more radiopaque and/or sonoreflective markers (not shown) These markers may be provided on any suitable location of anchoring member 16, and may be provided by any suitable means known to achieve the desired effect For example, a platinum/indium coil may be threaded over a portion of the sutures that are used to secure the polyester covering 16d

[0125] To facilitate connection to tension member 12, bridge 16c of posterior anchoring member 16 may be provided with a releasable connection mechanism 16e Connection mechanism 16e may allow the anchoring member 16 to be removed from the elongate tension member 12 and replaced, for example, by a different anchoring member with an alternate shape and size, depending on the particular anatomy of heart H and/or the desired effects on the heart H For example, in some embodiments, it may be desirable to utilize an anchoring member 16 that has a longer bridge 16c with greater spacing between contact zones 16a and 16b, to minimize mitral regurgitation. Accordingly, anchoring member 16 may be provided in a plurality of sizes, such as, for example, 2.0 centimeters, 2.5 centimeters, and 3.0 centimeters, measured from the midpoint of anchoring member 16 (e.g. , the tension member 12 attachment location) to the tip of the superior contact 16a.

[0126] Although the connection mechanism 16e may allow anchoring member 16 to be removed from the tension member 12 and replaced with another anchoring member 16, the position of the anchoring member 16 may remain fixed in that the final position of the anchoring member 16 along the linear aspect of the tension member 12 is fixed. However, in some embodiments, it is envisioned that the position of anchoring member 16 along the linear aspect of tension member 12 may be adjusted as desired.

[0127] Connection mechanism 16e may comprise a slot 16f for connecting to insert 12a. Slot 16f may have any suitable configuration for receiving insert 12a. For example, slot 16f may have a length, width, and height corresponding to the length, width, and height of insert 12a, respectively. In some embodiments, bridge 16c may be provided with an inwardly projecting rim 16g to prevent insert 12a from moving through bridge 16c in response to tension forced exerted by tension member 12.

[0128] In some embodiments, tension member 12 may intersect the bridge 16c of posterior anchoring member 16 closer to the inferior contact zone 16b than the superior contact zone 16a, as illustrated from the location of key-hole slot 16e in Fig. 5A, for example. The anchoring member 16 thus serves to provide a deformation of a superior portion of the left ventricle LV adjacent the annulus AN of the mitral valve MV, while allowing the tension member 12 to connect to anchoring member 16 at a position low enough to minimize interference between tension member 12 and the mitral valve MV structures. Although not depicted, in some embodiments, the inferior contact zone 16b may be made, for example, larger, than superior contact 16a, in order to balance the longer moment arm of the bridge 16c exerted by the superior contact zone 16d.

[0129] To facilitate delivery, such as, for example, percutaneous delivery of anchoring member 16, anchoring member 16 may be provided with a catheter attachment mechanism 16h Mechanism 16h may include any suitable mechanism for releasably attaching anchoring member 16 to a delivery catheter (discussed in greater detail below), and may be provided at any suitable location on anchoring member 16

[0130] Turning now to Figs 5B and 5C₁ mechanism 16h may be provided on a non-heart engaging surface 16q Surface 16q may be provided with a substantially circular recess 16r for receiving a portion of mechanism 16h Recess 16r may be provided with a through hole 16s for receiving another portion of mechanism 16h As depicted, through hole 16s may have a first opening in a floor of recess 16r, and a second opening (not shown) disposed under, for example, superior contact zone 16a

[0131] Mechanism 16h may include a post 16j defining a shank portion 16k and a head portion 161 Post 16j may be made of any suitable material, such as, for example, PEEK Shank portion 16k may include any suitable configuration so that it may be matingly received within opening 16s For example, as depicted, shank portion 16k may include a configuration that is substantially complimentary to the configuration of 16s Shank portion 16k may also include an opening (not shown) therein for receiving a fastener 16ι (e g , screw), to secure post 16j to anchoring member 16 Fastener 16ι may also be made from any suitable material, such as, for example, PEEK

[0132] Head portion 161 may include a plurality of geometric configurations for attachment to a delivery catheter For example, head portion 161 may include a plurality of circular disc-shaped formations 16m and a channel 16n in between the formations 16m Disposed in a plane above formations 16m, may be a substantially square- shaped formation 16o Formation 16o may define an opening 16p in the center of the formation 160, as illustrated

[0133] Turning to Figs 6A-6D, there is depicted an embodiment of an exemplary delivery catheter 60 for posterior anchoring member 16 The delivery catheter 60 may be configured to guide the posterior anchoring member into a desirable implantation position inside a patient's pericardial space As illustrated in Fig 6A, posterior anchoring member 16 may be attached to a distal end 61 of delivery catheter 60 [0134] Catheter 60 may include a catheter shaft 62 having a proximal end 62a and a distal end 62b Shaft 62 may be any suitable shaft to facilitate the delivery of anchoring member 16 For example, shaft 62 may include a single lumen tube 63 Tube 63 may have any suitable configuration For example, tube 63 may have a substantially cylindrical shape Tube 63 may have a substantially constant outer diameter of approximately 0 210 inches Additionally, some embodiments of tube 63 may also have a substantially constant inner diameter, while other embodiments may have a varying inner diameter For example, the inner diameter of tube 63 may be approximately 0 095 inches at the distal end 62b and approximately 0 125 inches at proximal end 62a

[0135] Additionally, embodiments of tube 63 may include a stainless steel braid (not shown) encased in any suitable material, such as, for example, PEBAX In some embodiments, the stainless steel braid may extend the entire length of tube 63 In other embodiments, stainless steel braid may extend for only a portion of tube 63 In embodiments where stainless steel braid extends the entire length of tube 63, the durometer "D" (or hardness) of the PEBAX material encasing the braid may be varied as desired

[0136] With continuing reference to Fig 6A, tube 63 may include three distinct segments defined by differing durometers of the PEBAX material encasing the stainless steel braid The three segments may include a distal segment 64, a middle segment 65, and a proximal segment 66 Proximal segment 66 may include a length of approximately 13 0 inches and be made of 63 durometer (D) PEBAX, middle segment 65 may be made of 63D PEBAX and may have a length of approximately 4 inches, and distal segment 64 may be made of 25D PEBAX and may have a length of approximately 4 5 inches In some embodiments, tube 63 may include a stainless steel hypotube (not shown) disposed within the tube 63 The hypotube may extend from actuator assembly 68 (discussed below in greater detail) for approximately 8 inches inside the tube 63 towards the distal segment 64 of tube 63 The hypotube may have any suitable configuration In some embodiments, the hypotube may include an inner diameter of approximately 0 09 inches and an outer diameter of approximately 0 125 inches

[0137] Distal segment 64 of tube 63 may be secured to an anchor attachment mechanism 67 by any suitable means For example, distal segment 64 may be pinned to mechanism 67 with a stainless steel pin (not shown) In some embodiments, distal segment 64 may be provided with one or more suitable coverings and/or coatings For example, distal segment 64 may include an FEP heat shrink wrap on the outside of tube 63

[0138] Turning now to Fig 6B, there is depicted an exemplary embodiment of anchor attachment mechanism 67 for attaching posterior anchoring member 16 to delivery catheter 60 Mechanism 67 may include a cap 67a fixedly secured to a distalmost end of distal segment 64 Cap 67a may have any suitable configuration to facilitate attachment of anchoring member 16 to catheter 60 For example, in some embodiments, cap 67a may have a substantially flat configuration with rounded edges 67b, so as to minimize trauma and irritation to a patient's bodily structures during delivery of anchoring member 16 Cap 67a may further include a through-hole 67c for accommodating an axle 67d Axle 67d may include any suitable configuration For example, axle 67d may include a fastener having a head portion 67e and a shank portion 67f Axle 67d may be made from any suitable material, such as, for example, PEEK Head portion 67e may be configured to have a relatively larger cross-sectional area than through-hole 67c, so as to retain axle 67d on cap 67a Shank portion 67f may have any suitable configuration and may be configured to be matingly received in opening 16p discussed above

[0139] Attachment mechanism 67 may further include a wheel 67g Wheel 67g may have any suitable configuration For example, wheel 67g may be provided with a recess 67h for securing formation 16o therein In some embodiments, wheel 67g may be keyed to axle 67d Wheel 67g may also be made of any suitable material For example, wheel 67g may be also made of PEEK Furthermore, wheel 67g may be provided with a plurality of radially extending flanges 67ι defining a channel 67j in between flanges 67ι Channel 67j may be configured for receiving an actuation cable 73 as discussed below in greater detail

[0140] Furthermore, attachment mechanism 67 may include a locking clip 67k for releasably securing attachment mechanism 67 to posterior anchoring member 16 Locking clip 67k may have any suitable configuration, and may be configured to releasably engage channel 16n Locking clip 67k may be operably connected to a pull- wire 74, as discussed in greater detail below In some embodiments, locking clip 67k may include a recess 67I for receiving and securing a portion of pull-wire 74 Additionally, locking clip 67k may be made of any suitable material, including, but not limited to, PEEK

[0141] Proximal segment 66 may be secured to an actuator assembly 68 by any suitable means For example, proximal segment 66 (including the hypotube discussed above) may be clamped to a suitable actuator, such as, for example, handle 68 Handle 68 may be configured to control the positioning and deployment of anchoring member 16

[0142] Handle 68 may be made of any suitable material to achieve the desired effect For example, handle 68 may be made of urethane Furthermore, handle 68 may include any suitable configuration, shape, and size For example, handle 68 may include a generally elongated shape, and may be configured to be comfortably operated with one hand As shown in Fig 6C, handle 68 may include a number of control mechanisms, including, but not limited to, steering mechanism 70 and release mechanism 80 Steering mechanism 70 and release mechanism 80 may be disposed within a handle housing 69, for example

[0143] Steering mechanism 70 may include any suitable mechanism known to those of ordinary skill in the art, and may be used to rotate pad attachment mechanism 67, as desired, so as to position posterior anchoring member 16 in an appropriate implantation position Steering mechanism 70 may include a lever 71 rotatably disposed within housing 69 of handle 68 Lever 71 may be accessible to an operator through an opening 69a in housing 68 Furthermore, lever 71 may include any configuration conducive to facilitating rotation of lever 71 For example, lever 71 may include a projection 72 configured to be actuated by an operator's thumb

[0144] Lever 71 may be operably connected to a cable 73 that controls rotation of anchoring member 16 Cable 73 may have any suitable configuration to achieve the desired effect For example, in some embodiments, cable 73 may include a plurality of wires braided together In other embodiments, cable 73 may include a cylindπcally- shaped monofilament wire Cable 73 may be made of any suitable material For example, cable 73 may be made of polyethylene In some embodiments, cable 73 may be provided with one or more coatings and/or coverings For example, cable 73 may be provided with a lubπcious coating to, for example, facilitate movement within tube 63, as discussed below Furthermore, cable 73 may be secured to lever 71 by any suitable means For example, in some embodiments, cable 73 may be pinned with, for example, a stainless steel pin (not shown), to steering mechanism 70 disposed within housing 69

[0145] In the depicted embodiment, cable 73 may be slidably disposed within tube 63 In particular, cable 73 may be configured to extend to attachment mechanism 67 through tube 63 As shown in Fig 6B, cable 73 may extend through distal segment 64 of tube 63, may be received in channel 67j, loop around wheel 67h, and extend back through tube 63 to steering mechanism 70, where it may be secured with, for example, another stainless steel pin (not shown) Cable 73 may be secured to wheel 67h by any suitable means known in the art For example, in some embodiments, cable 73 may be locked in place around wheel 67h by one or more cable locking stainless steel pins (not shown) and/or adhered with cyanoacrylate adhesive

[0146] As alluded to above, movement of lever 71 may result in movement, for example, rotational movement, of posterior anchoring pad 16, as depicted in Fig 6D When fully rotated in either direction, posterior anchoring member 16 may be oriented approximately 90° to catheter 60 Therefore, in order to communicate a position of anchoring member 16 to an operator, housing 69 may be provided with one or more indictors 69b, as shown in Fig 6C Indicators 69b may include any suitable indicator known in the art, including, but not limited to, alpha-numeric characters, graphic designs, colors, and/or tactile configurations For example, in the disclosed embodiment, housing 69 may be marked with a "0", or an arrow, that indicates to an operator when posterior anchoring member 16 is in a straight line with delivery catheter 60

[0147] Release mechanism 80 may include any suitable mechanism configured to facilitate disengaging anchoring member 16 from delivery catheter 60 In the disclosed embodiment, release mechanism 80 may include a lever arm 81 rotatably secured to housing 69 of handle 68 Lever arm 81 may include any suitable lever arm to achieve the desired effect Lever arm 81 may be configured to rotate between a first, closed position (shown in solid lines in Fig 6C) and a second, open position (shown in phantom lines in Fig 6C) When in the closed position, lever arm 81 may be configured to lie substantially flat with other portions of housing 69 Furthermore, lever arm 81 may be rotatably secured to housing 69 by any suitable means, such as, for example, by a pivot pin 82 As shown in Fig 6C, lever arm 81 may be configured to rotate about pivot pin 82

[0148] Furthermore, in some embodiments, lever arm 81 may be secured against unintentional rotation with a suitable safety mechanism 83 Safety mechanism 83 may include any suitable mechanism for achieving the desired effect For example, safety mechanism 83 may include a tamper proof seal releasably securing lever arm 81 to housing 69 In some embodiments, the tamper proof seal may include a 0 25 inch wide perforated polypropylene tape that may be configured to be selectively removed from lever arm 81 when desired

[0149] With references to Figs 6B and 6C, lever arm 81 may be operably connected to a pull-wire 74 Lever 81 may be operably connected to pull-wire 74 by any suitable means For example, pull-wire 74 may be anchored to lever arm with a plurality of fasteners (not shown), such as, for example, set screws Pull-wire 74 may include any suitable configuration In some embodiments, pull-wire 74 may include a stainless steel wire having a substantially cylindrical configuration At a distalmost end, pull-wire 74 may be provided with a geometric configuration (e g , a ball) 74a for facilitating connection to locking clip 67k Geometric configuration 74a may be received within recess 671 in order to operably connect pull-wire 74 to locking clip 67k Pull-wire 74 may be configured to extend to attachment mechanism 67 through tube 63 of delivery catheter 60

[0150] In use, posterior anchoring member 16 may be released from catheter 60 by first removing or cutting the safety mechanism 83 and then rotating lever arm 81 from the first, closed position to the second, open position Such rotation of lever arm 81 may retract pull-wire 74, which by virtue of its connection to locking clip 67k, may retract locking clip 67k, thereby releasing attachment mechanism 67 from post 16j

[0151] It is important to note that while an exemplary embodiment of a medical device 10 is described above, variations are also considered within the scope of the invention Mitral valve and cardiac anatomy may be quite variable from patient to patient, and mitral valve splint design and implant position may vary accordingly For example, the location of the regurgitant jet may be centered, as shown in Fig 2A, or may favor one side of the valve opening Therefore, differences in anchoring member size, anchoring member shape, and overall device location, for example, may be required to best modify the heart chamber and valve annulus for a particular patient Steps taken during the delivery of the medical device 10 are useful to identify and incorporate these design and position variables to suit the particular cardiac anatomy and mitral valve dysfunction

[0152] As will be discussed below in greater detail, the delivery of medical device 10 may require the use of various surgical tools Furthermore, as alluded to above, since the medical device 10 may be configured for implantation via a percutaneous subxiphoid approach, several various tools may be utilized at varying stages of implantation Implantation of the medical device 10 may be accomplished in essentially four discrete stages These stages may be characterized as (1) Percutaneous Pericardial Access, (2) Site Identification, (3) Device Implantation, and (4) Sizing and Therapeutic Evaluation The tools useful in each of these stages will be discussed sequentially hereinafter

[0153] Description of Percutaneous Pericardial Access Tools

[0154] Turning now to Figures 7 and 7A, there is illustrated an embodiment of an introducer 700 that is configured for bluntly navigating through tissue from an epidermal incision point to the intended pericardial access location The introducer may be any suitable introducer to achieve the desired effect For example, introducer 700 may be the type of introducer that is commonly referred to as an "8F introducer" (ι e an 8 French introducer)

[0155] Furthermore, introducer 700 may be comprised of a tube 701 having a distal end 701a and a proximal end 701 b, and defining a lumen 702 therein Tube 701 may include any suitable configuration For example, tube 701 may include a hypotube having a substantially cylindrical shape and a substantially circular cross-sectional area Tube 701 may also have any suitable dimensions to achieve the desired effect For example, tube 701 may have a length of approximately 6 5 inches, an inner diameter of approximately 0 11 inches, and an outer diameter of 0 13 inches Additionally, tube 701 may be made of any suitable bio-compatible material For example, tube 701 may be made of stainless steel

[0156] With continued reference to Figures 7 and 7A, introducer 700 may include blunt-tipped polymeric obturator 703 Obturator 703 may be either fixedly or movably secured to distal end 701a of tube 701 The obturator 703 may have any suitable configuration and may be made of any suitable material For example, the obturator 703 may include a white PEBAX tube having an outer diameter of approximately 0 1 inches and a length that may be slightly longer than tube 701

[0157] A proximal end of obturator 703 may be secured to a double-ended cap 705 Cap 705 may be secured to obturator 703 by any suitable means available For example, cap 705 may be bonded with an epoxy to obturator 703 In addition, cap 705 may interface with a female luer 704 connected to proximal end 701 b of tube 701 In some embodiments, female luer 704 may be provided with a plurality of geometric projections 707 for facilitating insertion and manipulation of introducer 700 Geometric projections may include any suitable configuration As shown in Fig 7, geometric configurations may include projections extending radially away from a body of female luer 704

[0158] To facilitate visualization of introducer 700 during a procedure, introducer 700 may be provided with one or more radiopaque and/or sonoreflective markers 706 These markers may be provided on any suitable location of introducer (e g , on an external surface of tube 701 ), and may be provided by any suitable means known to achieve the desired effect

[0159] With reference now to Figs 8A-C, there is illustrated an embodiment of a pericardial access needle 800 Needle 800 may be configured to penetrate a patient's pericardial sac to provide access to the patient's pericardial space without penetrating the epicardial surface of the heart H Needle 800 may include a substantially rigid tube 801 defining a lumen 802 therein Tube 801 may have a proximal end portion 801a and a distal end portion 801 b, and may have any suitable configuration to achieve the desired effect For example, tube 801 may have a substantially cylindrical shape and a substantially circular cross-sectional area Tube 801 may be made of any suitable biocompatible material, including, but not limited to, stainless steel Tube 801 may be configured to be slightly longer than introducer 700, and may include a length of approximately 8 inches Tube 801 may include a substantially constant or varying inner diameter For example, the inner diameter of tube 801 may be approximately 0 02 inches at the distal tip 81 1 , and may transition to approximately 0 05 inches within 0 30 inches of the tip 811 Furthermore, in some embodiments, tube 801 may be provided with a visual marker 803 positioned approximately 6 5 inches from a distalmost end of needle 800, so as to indicate to an operator when the distalmost end of needle 800 will exit the introducer 700

[0160] With specific reference to Fig 8B, there is depicted an exemplary embodiment of distal end portion 801 b Distal end portion 801 b may include a distal end 810 defining a sharp, pointed tip 811 Tip 811 may have any suitable configuration to achieve the desired effect of, for example, penetrating a patient's pericardial sac In particular, embodiments of tip 811 may have a length of approximately 0 080 inches Distal end portion 801b may further include an abrupt decrease in diameter defining a gap 812 immediately proximal of tip 1 1 Gap 812 may have any suitable configuration to, for example, accommodate the thickness of a patient's pericardial sac (pericardium) and retain or "capture" a patient's pericardium therein For example, gap 812 may include a length of approximately 0 020 inches Immediately proximal of gap 812, distal end portion 801b may be provided with an abrupt increase in diameter or step 813 Step 813 may function as a "stop" to limit maximum penetration of needle 800 into a patient's pericardial sac to about 0 080 inches

[0161] Since the thickness of a patient's pericardium may vary from patient to patient, it is contemplated that needle 800 may be made available in at least three differing embodiments In the first embodiment, gap 812 may have the above-described length of 0 020 inches In the second and third embodiments, gap 812 may have a length of approximately 0 040 inches and 0 060 inches, respectively

[0162] With renewed references to Figs 8A and 8C, proximal end portion 801a may be secured to, for example, a male luer 804 by any suitable means For example, proximal end portion 801a may be bonded to male luer 804 with epoxy Male luer 804 may then be coupled to a female luer 805, for example Female luer 805 may then be attached to, for example, clear polyvinyl chloride (PVC) tubing 806 by any suitable means For example, female luer 805 may also be bonded to tubing 806 with epoxy Tubing 806 may have any suitable length For example, tubing 806 may have a length of approximately 12 inches Furthermore, a proximal end 806a of tubing 806 may be secured to any suitable connection capable of facilitating contrast injections and insertion of a guidewire into tube 801 For example, proximal end 806a may be bonded with epoxy to a Y-adapter 807 and Touhy 808, as depicted in Fig 8C

[0163] Turning now to Fig 9, there is depicted an exemplary embodiment of a pericardial guidewire 900, in accordance with the principles of the present disclosure Guidewire 900 may be configured for passage through access needle lumen 802 of access needle 800 after needle 800 has been secured to a patient's pericardium Guidewire 900 may have any suitable configuration to achieve the desired effect For example, guidewire 900 may include a width of 0 018 inches Guidewire 900 may include a length of approximately 43 inches Furthermore, although some embodiments of guidewire 900 may include a substantially uniform cross-sectional area through the entire length of guidewire 900, the illustrated embodiment of guidewire 900 may include a substantially tapered distal portion 901

[0164] As shown in Fig 9, tapered distal portion 901 may include a substantially flat ribbon portion 901a defining the distal tip of distal portion 901 Ribbon portion 901a may extend approximately 0 5 inches proximally from the distal tip 910b of distal portion 901 , and may include a width of approximately 0 003 inches and a height of approximately 0 001 inches In some embodiments, guidewire 900 may be provided with a coil 902 about a substantial portion of tapered distal portion 901 Coil 902 may be made of a coil wire having a diameter of approximately 0 003 inches and a composition of approximately 8% Tungsten and 92% platinum Coil 902 may be secured to portions of wire 900 by any suitable means For example, coil 902 may be brazed to a proximal location of guidewire 900 and may be welded to the ribbon portion 901a Distal tip 910b is a soft, flexible tip

[0165] Guidewire 900 may be used in conjunction with other standard commercially available devices to further gain access into a patient's pericardial space These devices may include, but are not limited to, a 0 035 inch guidewire, an exchange device for substituting the 0 018 inch guidewire for the 0 035 inch guidewire, and a balloon dilatation catheter compatible with 0 035 inch guidewire and 20-25 millimeters in diameter

[0166] Turning now to Figs 10A-10C, there is depicted an access sheath 1000 that may include a flexible polymer tube assembly configured to, among other things, create and maintain an access conduit for delivery of medical device 10 into a patient's pericardial space Access sheath 1000 may include a substantially cylindrical shape and may comprise a sheath 1010, a dilator 1020, and securement clamp 1030, as depicted as Fig 10A

[0167] With specific reference to Fig 10B, sheath 1010 may include tube 101 1 defining a lumen therein Tube 1011 may include any suitable configuration and be made of any suitable material For example, tube 1011 may be a 53F tube having a length of approximately 8 inches Both inner and outer surfaces of tube 1011 may be provided with one or more coatings, such as, for example, a lubπcious parylene coating, to facilitate, for example, insertion of tools within tube 101 1 Furthermore, tube 1011 may include at least three discrete portions These portions may include a distal tip 1012, a mid-segment 1013, and a proximal segment 1014

[0168] Distal tip 1012 may be made of any suitable material For example, distal tip 1012 may be made of 20% barium loaded acrylontrile butadiene styrene (ABS) material Furthermore, distal tip 1012 may have any suitable configuration For example, distal tip 1012 may include a substantially cylindrical shape defining a lumen therein Distal 1012 may have an inner diameter of approximately 0 70 inches and a maximum outer diameter of 0 85 inches As shown in Fig 10B, distal tip 1012 may include at least one angled edge 1012a, such that tip has a length of approximately 1 19 inches on one side ("the long side") and approximately 0 40 inches on an opposing side ("the short side") Additionally, the short side of tip 1012 may include one or more geometric configurations For example, short side of tip 1012 may include a lip 1012b Lip 1012b may extend radially away from tip 1012 and may include a length of approximately 0 10 inches

[0169] With continuing reference to Fig 10B, a proximal portion 1012c of distal tip 1012 may be fixedly secured to distal portion 1013b of mid-segment 1013 Tip 1012 may be secured to mid-segment 1013 by any suitable means For example, tip 1012 may be bonded to mid-segment 1013 with cyanoacrylate Alternatively, tip 1012 and mid-segment 1013 may be fabricated as a single, unitary piece Mid-segment 1013 may include a tube 1013a having any suitable configuration For example, tube 1013a may include a substantially cylindrical shape and a substantially circular cross-sectional area Tube 1013a may include any suitable dimensions For example, tube 1013a may include a length of approximately 4 inches, an inner diameter of approximately 0 70 inches and an outer diameter of approximately 0 79 inches

[0170] Furthermore, it is contemplated that mid-segment 1013 may be configured to be flexible In particular, mid-segment 1013 may be made relatively more flexible than proximal segment 1014, which is discussed in greater detail below Mid-segment 1013 may be made from any suitable bio-compatible material For example, mid- segment 1013 may be made from silicone material that is reinforced with a continuous stainless steel coil (not shown) In some embodiments, the stainless steel coil may be disposed within the silicone material Additionally, mid-segment 1013 may be made by any suitable manufacturing process including, but not limited to, extrusion

[0171] A proximal portion 1013c of mid-segment 1013 may be fixedly secured to a distal portion 1014d of proximal segment 1014 by any suitable means For example, mid-segment 1013 may be bonded to proximal segment 1014 with cyanoacrylate adhesive Proximal segment may include a tube 1014a having any suitable configuration For example, tube 1014a may include a substantially cylindrical tube having a length of approximately 3 6 inches, an inner diameter of approximately 0 70 inches, and an outer diameter of approximately 0 85 inches

[0172] As alluded to above, proximal segment 1014 may be made relatively rigid when compared to mid-segment 1013 Accordingly, proximal segment 1014 may be made of any suitable material, including, but not limited to, polycarbonate

[0173] Proximal segment 1014 may be provided with a plurality of markings 1014b-1014c on an external surface to indicate to an operator (e g , surgeon) when lip 1012b of distal tip 1012 is engaged with a patient's pericardium In particular, it is contemplated that proximal segment 1014 may be provided with a first marker 1014b that corresponds to the long side of distal tip 1012 and a second marker 1014c that corresponds to the short side of distal tip 1012 Marker 1014b may include, for example, a graphic representing a locked padlock, and marker 1014c may include, for example, a graphic representing an unlocked padlock, as depicted in Fig 10B However, those having ordinary skill in the art will readily recognize that any suitable indicating system and/or markings may be utilized within the principles of the present disclosure

[0174] In use, it is contemplated that if the locked symbol (e g , marker 1014b) is in an anterior position, it may signify that the lip 1012b of distal end 1012 may be engaged with a patient's pericardium However, if the unlocked symbol (e g , marker 1014c) is in the anterior position, it may signify that the lip 1012b is not engaged with the patient's pericardium

[0175] Together, distal tip 1012, mid-segment 1013, and proximal segment 1014 may define a substantially cylindrical tube having a substantially constant inner diameter, but a varying outer diameter, as depicted However, in some embodiments, it is contemplated that distal tip 1012, mid-segment 1013, and proximal segment 1014 may define a tube have a varying inner diameter while having a substantially constant outer diameter

[0176] Turning now to Fig 10C, there is depicted an embodiment of dilator 1020, in accordance with the principles of the present disclosure Dilator 1020 may include a distal tip 1021 , a body 1022, and a proximal handle 1023 As shown in Fig 10C, dilator

1020 may include a substantially cylindrical configuration with a tapering distal portion Dilator may further include a through lumen 1024 extending along a longitudinal axis of dilator 1020 Lumen 1024 may include any suitable configuration for accommodating the 0 035 inches guidewire discussed above For example, lumen 1024 may have a substantially circular cross-sectional configuration and may have an inner diameter of approximately 0 042 inches

[0177] Distal tip 1021 may include a length of approximately 3 7 inches Distal tip

1021 may have a substantially conical external shape, such that the outer diameter of distal tip 1021 transitions from approximately 0 118 inches at the distal end of distal tip 1021 to approximately 0 67 inches over the length of distal tip 1021 Distal tip 1021 may further include any suitable material For example, distal tip 1021 may made of approximately 15% to 18% barium loaded silicone material [0178] Since distal tip 1021 , by virtue of its tapered configuration, may be susceptible to damage during, for example, shipment and/or storage, some embodiments of dilator 1020 may include a removable mandrel (not shown) disposed within lumen 1024 to prevent damage to, among other things, distal tip 1021

[0179] Body 1022 of dilator 1020 may include any suitable configuration For example, as depicted, body 1022 may include a substantially cylindrical shape having a substantially constant circular cross-sectional area Body 1022 may be secured to distal tip 1021 by suitable means, including, but not limited to, a suitable adhesive However, body 1022 and distal tip 1021 may be made of a unitary one-piece construction Furthermore, body 1022 may be made of any suitable material For example, body 1022 may be made of silicone

[0180] As noted above, dilator 1020 may be provided with a handle 1023 Handle 1023 may include any suitable configuration and may include a silicone pad having a width of approximately 1 25 inches, a length of approximately 1 75 inches, and a thickness of approximately 0 5 inches Handle 1023 may be secured to a proximal portion of body 1022 by any suitable means For example, handle 1023 may be bonded to body 1022 with room temperature vulcanizing (RTV) sealant Alternatively, handle 1023 and body 1022 may be made of a unitary one-piece construction

[0181] Dilator 1020 may be provided with one or more coatings on an outer surface, for example In particular, it is contemplated that the entire outer surface of dilator 1020 may be provided with a lubricious parylene coating

[0182] With reference now to Figs 10A and 10D, securement clamp 1030 may be configured to secure dilator 1020 within sheath 1010 Additionally, securement clamp 1030 may be used to secure access sheath 1000 in a desired location by placing clamp 1030 on proximal segment 1014 at a location that maintains retraction of the sheath to a patient's chest As illustrated, clamp 1030 may include two substantially symmetrical halves 1031a and 1031b Halves 1031a and 1031b may be secured together by any suitable means For example, halves 1031a and 1031b may be secured together by a hinged component 1032 Halves 1031 a and 1031 b may be made of any suitable material, such as, for example, acetal Furthermore, clamp 1030 may include a means, such as, for example, screw tightening closure mechanism 1033, for tightening halves 1031a and 1031 b together when, for example, clamp 1030 is mounted over handle 1023 and proximal segment 1014 Screw tightening closure mechanism

1033 may be configured to draw halves 1031a and 1031b together when the screw or bolt 1033a is tightened by rotation

[0183] As shown in Fig 10D, when secured together, halves 1031a and 1031b may define a substantially cylindrical channel 1034 for receiving proximal segment 1014 When halves 1031a and 1031b may be tightened together, cylindrical channel

1034 may include an inner diameter of approximately 0 84 inches

[0184] Turning now to Fig 11 , there is depicted an exemplary embodiment of a catheter securement clip 1 100, in accordance with the principles of the present disclosure Clip 1100 may be configured to slide over a proximal portion of access sheath 1000 (external to the patient) and stabilize the various catheters and components described in connection with the principles of the present disclosure

[0185] As illustrated, clip 1100 may include a hinged clamp 1101 Hinge clamp 1101 may include any suitable clamp to achieve the desired purpose For example, hinge clamp 1101 may include two substantially symmetrical halves 1101a and 1101b secured together with a screw tightened closure mechanism 1102 As illustrated, halves 1101a and 1101 b, when secured together, may define a substantially cylindrical channel 1103 for receiving a portion of proximal segment 1014 When halves 1101a and 1101b may be tightened together, cylindrical channel 1 103 may include an inner diameter of approximately 0 84 inches Furthermore, halves 1101a and 1 101 b may be made of any suitable material, such as, for example, acetal

[0186] Clamp 1101 may further include a plurality of malleable posts 1104 and 1105 extending proximally from clamp 1101 Posts 1104 and 1105 may include any suitable configuration for holding various anterior and/or posterior implantation devices utilized within the principles of the present disclosure For example, posts 1104 and 1 105 may comprise a substantially cylindrical shape Additionally, each of posts 1104 and 1 105 may comprise an aluminum wire (not shown) of approximately 4 inches in length with a white polyolefin coating disposed over the wire Furthermore, the distal ends 1104a and 1105a of posts 1 104 and 1105 may be secured to clamp 1101 by any suitable means For example, distal ends 1104a and 1105a may be pinned to clamp 1101 The proximal ends 1 104b and 1105b of posts 1104 and 1 105 may be secured to any suitable mechanism for holding the various anterior and/or posterior implantation devices utilized within the principles of the present disclosure For example, each of proximal ends 1104b and 1 105b may be pinned to a polycarbonate spring-loaded pinch clip 1106 and 1107

[0187] Description of Site Identification Tools

[0188] Turning now to Figs 12A-B, there are illustrated exemplary embodiments of a vacuum tubing set 1200 for use during implantation of medical device 10 Vacuum tubing set 1200 may be configured to supply vacuum from a vacuum source (not shown) to the delivery system devices (discussed in greater detail below), in accordance with the principles of the present disclosure In the embodiment depicted in Fig 12A, vacuum tubing set 1200 may include a tubing set that bifurcates into a "Y" at a distal end In one embodiment, tubing set 1200 may include a tube 1201 having a proximal end 1201a and a distal end 1201b Tube 1201 may include any suitable configuration known to those having ordinary skill in the art For example, tube 1201 may include a length of approximately 150 inches, an inner diameter of 0 24 inches, and an outer diameter of 0 38 inches

[0189] At proximal end 1201 a, tube 1201 may be provided with a suction connector 1202, for connection to a vacuum source At distal end 1201b, tube 1201 may be bifurcated into furcations 1201c and 1201d by a "Y" shaped connector 1203 Connector 1203 may include any suitable connector, such as, for example, a clear PVC connector commonly available to those having ordinary skill in the art Connector 1203 may serve to bifurcate distal end 1201b of tube 1201 into furcations 1201c and 1201d The distal ends of each of furcations 1201c and 1201d may be provided with any suitable valve mechanisms for controlling the vacuum pressure at a distal end of tube 1201 For example, each of furcations 1201c and 1201d may include a high flow 3-way stopcock 1204

[0190] In the embodiment depicted in Fig 12B, tubing set 1200 may include a substantially straight tube 1210 While tube 1210 may be substantially similar to tube 1201 , tube 1210 may include a length of approximately 75 inches and may be provided with suction connectors 1202 at both proximal and distal ends of the tube 1210 Tube 1210 may further include a suitable in-line suction filter 1205 at approximately a mid- segment of tube 1210

[0191] With reference now to Fig 13, there is depicted an embodiment of a vacuum line for use with the above-described vacuum tubing set embodiments Vacuum line 1300 may be configured to facilitate the supply of vacuum from the above- described vacuum tubing set embodiments to the delivery devices of the present disclosure

[0192] Embodiments of vacuum line 1300 may include a tube 1301 constructed from, for example, PEBAX material Furthermore, tube 1301 may have any suitable configuration to achieve the desired purpose For example, tube 1301 may include a length of approximately 36 inches, an inner diameter of 0 13 inches, and an outer diameter of 0 18 inches Tube 1301 may be further provided with a continuous stainless steel wire spring coil (not shown) disposed within a lumen (not shown) of tube 1301 The stainless steel wire may have a diameter of approximately 0 016 inches and may be coiled into a tube having a diameter of 0 125 inches

[0193] Furthermore, embodiments of tube 1301 may include a female luer 1302 connected to one end and a male luer 1303 connected to the other opposing end, as depicted The luers may be secured to tube 1301 by any suitable means For example, luers 1302 and 1303 may be friction fit onto tube 1301 In some embodiments, tube 1301 may be provided with a polyolefin heat shrink wrap 1304 over the external surface of tube 1301 for identification purposes It is contemplated the heat shrink wrap 1304 may be provided with identifying marks, such as, for example, alpha-numeric labels [0194] Turning now to Figs 14A-14B, there is depicted an embodiment of an intracardiac echo (ICE) delivery catheter 1400, in accordance with the principles of the present disclosure The ICE delivery catheter 1400 may be configured to facilitate the placement and control of the echocardiography imaging catheters (discussed in greater detail below) required for visualization during implantation of medical device 10 The ICE delivery catheter 1400 may have any suitable configuration to achieve the desired effect In one embodiment, the ICE delivery catheter 1400 may include a single lumen catheter having a length of approximately 25 inches However, in other embodiments, ICE catheter 1400 may include a greater or lesser number of lumens

[0195] As shown in Fig 14A, ICE delivery catheter 1400 may include a proximal strain relief 1401 , a Touhy 1402, a vacuum manifold 1403, a catheter shaft 1404 with a distal shapeable segment 1404b, and a distal vacuum stabilization cup 1406

[0196] Proximal strain relief 1401 may include a single lumen tube 1401a Tube 1401a may have any suitable configuration For example, tube 1401a may include a length of approximately 4 inches, an inner diameter of 0 24 inches, and an outer diameter of 0 38 inches In some embodiments, tube 1401a may have more than one lumen Tube 1401a may be made from any suitable material, such as, for example, PVC In some embodiments, tube 1401a may be secured to a hypotube 1401 b A distal portion of tube 1401a may be secured to a proximal portion of hypotube 1401b by any suitable means For example, tube 1401a may be bonded with, for example, ultraviolet adhesive (acrylate urethane blend) to hypotube 1401 b

[0197] Hypotube 1401b may include any suitable configuration In some embodiments, hypotube 1401 b may include a length of approximately 0 25 inches, an inner diameter of 0 22 inches, and an outer diameter of approximately 0 25 inches A distal portion of hypotube 1401b may be connected to a proximal portion of Touhy 1402 by any suitable means For example, hypotube 1401b may be bonded to Touhy 1402 with an epoxy

[0198] Touhy 1402 may be utilized to facilitate securing the ICE imaging catheter to the ICE delivery catheter 1400, as will be discussed in greater detail below Furthermore, a distal portion of Touhy 1402 may be connected to a proximal portion of vacuum manifold 1403 Touhy 1402 may be connected to vacuum manifold 1403 by any suitable means For example, Touhy 1402 may be snap-fit to vacuum manifold 1403 Vacuum manifold 1403 may be made of any suitable material For example, vacuum manifold 1403 may be made from polycarbonate Vacuum manifold 1403 may have any suitable configuration known to those of ordinary skill in the art For example, vacuum manifold 1403 may have a length of approximately 5 inches Furthermore, vacuum manifold 1403 may contain an inner through lumen (not shown) and a side vacuum port 1403a for connection to, for example, a vacuum source (not shown)

[0199] In some embodiments, a distal portion of vacuum manifold 1403 may be connected to a second stainless steel hypotube (not shown) similar to hypotube 1401 b The second hypotube may have any suitable configuration, such as, for example, a length of approximately 1 inch A proximal portion 1404a of catheter shaft 1404 may be fed into a distal end of the second hypotube and secured therein by, for example, being bonded with an epoxy In some embodiments, a polyolefin heat shrink of, for example, approximately 1 inch in length, may be placed over the epoxy bond to, for example, reinforce the bond

[0200] Catheter shaft 1404 may have any suitable configuration For example, catheter shaft 1404 may have a length of approximately 20 inches Furthermore, as alluded to above, catheter shaft 1404 may include a proximal segment 1404a and a distal segment 1404b Proximal segment 1404a may be approximately 17 inches in length and may include any suitable tube For example, proximal segment 1404a may comprise a 20% Barium loaded, 62D₁ blue PEBAX tube The PEBAX tube may include a reinforcement provided by, for example, a stainless steel braid Furthermore, in some embodiments, proximal segment 1404a may be provided with one or more lumens therein Furthermore, proximal segment 1404a may include an inner diameter of approximately 0 195 inches and an outer diameter of approximately 0 213 inches In some embodiments, an external surface of proximal segment 1404a may be provided with markings suitable for determining a position of ICE catheter 1400 relative to, for example access sheath 1000 In particular, it is contemplated that white numerical markings may be located on an outer surface of proximal segment 1404a, approximately 8 inches from the distal tip The numerical markings may be spaced from each other by approximately 1 centimeter, and may collectively extend for approximately 10 centimeters proximally

[0201] With references to Figs 14A-14B, distal segment 1404b may include any suitable configuration For example, distal segment 1404b may have a length of approximately 3 inches Furthermore, distal segment 1404b may include a stainless steel hypotube 1405 disposed within the same shaft material as proximal segment 1404a Hypotube 1405 may have any suitable configuration For example, hypotube 1405 may include a plurality of slots 1405a within a length of approximately two inches near the distal end Additionally, the hypotube 1405 may include an inner diameter of 0 164 inches and an outer diameter of 0 188 inches Furthermore, in some embodiments, the outer distal segment 1404b may include one or more coatings and/or coverings For example, an outer portion of distal segment 1404b may include a 20% - 25% Barium loaded, 25D, blue PEBAX covering

[0202] A distal end of catheter shaft 1404 may be connected to a vacuum stabilization cup 1406 by any suitable means For example, shaft 1404 may be pinned to cup 1406 with pins 1407 Cup 1406 may be made of any suitable material, including, but not limited to, polycarbonate Cup 1406 may have any suitable configuration For example, cup 1406 may include a length of approximately 0 85 inches, a width of approximately 0 4 inches, and a height of approximately 0 18 inches Additionally, an inner portion of cup 1406 may be provided with a through lumen 1408 to hypotube 1405

[0203] To facilitate visualization of cup 1406 during, for example, a procedure, cup 1406 may be provided with one or more radiopaque and/or sonoreflective features These features may be provided on any suitable location of cup 1406, and may be provided by any suitable means known to those of ordinary skill in the art For example, cup 1406 may be provided with a plurality of coils bonded to a pericardial surface of cup 1406 with an ultraviolet adhesive Coils may include platinum/indium coils having a composition of 90% platinum and 10% indium

[0204] Turning now to Figs 15A-15E, there is depicted an exemplary embodiment of a posterior sighting catheter 1500, in accordance with the principles of this disclosure Posterior sighting catheter 1500 may be configured to facilitate identification of proper epicardial location for placement of posterior anchoring member 16 and introduction of posterior needle (discussed in greater detail below)

[0205] The posterior sighting catheter 1500 may include any suitable configuration For example, posterior sighting catheter 1500 may include a dual-lumen catheter having a length of approximately 28 inches Posterior sighting catheter 1500 may include a greater or lesser number of lumens and may include any suitable length to achieve the desired purpose

[0206] With specific reference to Fig 15A, posterior sighting catheter 1500 may include a vacuum manifold 1502, a vacuum lumen catheter shaft 1504, a needle lumen catheter shaft 1506, a needle lumen steering mechanism 1508, and a distal cup 1510 Vacuum manifold 1502 may include any suitable configuration For example, manifold 1502 may include two through lumens (not shown), namely a vacuum lumen (that, in some embodiments, may begin at a distal end of manifold 1502 and may exit on a side of manifold 1502) and a needle lumen (that, in some embodiments, may begin at a distal end of manifold 1502 and may exit at a proximal end of manifold 1502) Furthermore, in some embodiments, manifold 1502 may include a luer hub 1502a operably connected to the vacuum lumen opening, creating a vacuum port 1502b Luer hub 1502a may be connected to the vacuum lumen opening by any suitable means For example, luer hub 1502a may be bonded with, for example, ultraviolet adhesive and may be threaded into the side of manifold 1502 at the vacuum lumen opening to create vacuum port 1502b Additionally, a Touhy 1503 may be connected to the proximal end of manifold 1502 at the needle lumen through-hole location The Touhy 1503 may be connected to manifold 1502 by any suitable means For example, Touhy 1503 may also be bonded with, for example, ultraviolet adhesive, and may be threaded into the proximal end of the manifold 1502 at the needle lumen through-hole location.

[0207] The distal end opening of vacuum lumen may be operably connected to a proximal end 1504a of vacuum lumen shaft 1504. For example, the proximal end 1504a of catheter 1504 may be bonded with any suitable adhesive (e.g., ultraviolet adhesive) to the distal end opening of the vacuum lumen. The distal end opening of the needle lumen may be similarly bonded to a stainless steel hypotube (not shown). The hypotube may have any suitable configuration. For example, the hypotube may have a length of approximately 7.5 inches, an inner diameter of approximately 0.135 inches, and an outer diameter of approximately 0.148 inches. Furthermore, in some embodiments, manifold 1502 may be provided with one or more suitable coverings, markings, and/or indicators. For example, in the disclosed embodiment, manifold 1502 may include a polyolefin heat shrink 1502c disposed about an external surface of manifold 1502.

[0208] With references now to Figs. 15A-15B, vacuum lumen catheter shaft 1504 may include any suitable configuration. For example, shaft 1504 may include a length of approximately 21 inches and may define a lumen 1504b therein. Furthermore, shaft 1504 may be constructed from any suitable material. For example, shaft 1504 may be constructed from PEBAX material having varying durometers. It particular, it is contemplated that shaft 1504 may be constructed from PEBAX material ranging in durometer from approximately 7OD at a proximal portion of shaft 1504 to approximately 40D at a distal portion of shaft 1504. Furthermore, in some embodiments, shaft 1504 may include one or more shaft reinforcement mechanisms, such as, for example, a stainless steel braid, disposed within or about shaft 1504.

[0209] In some embodiments, shaft 1504 may contain a stiffening mechanism. For example, as shown n Fig. 15B, shaft 1504 may include one or more stiffening wires 1504c. Stiffening wires 1504c may include any suitable configuration and may be made of any suitable material. For example, stiffening wires 1504c may be made of stainless steel, may include a diameter of 0.013 inches, and may include a substantially circular cross-sectional area Furthermore, in some embodiments, stiffening wires 1504c may be embedded within the PEBAX material of shaft 1504

[0210] With continued reference to Fig 15B, shaft 1504 may include any suitable configuration For example, shaft 1504 may include a substantially constant inner diameter of approximately 0 09 inches However, in some embodiments, the inner diameter of shaft may be variable along the length of shaft 1504 Additionally, shaft 1504 may include an outer diameter of approximately 0 22 inches at a proximal portion and 0 19 inches at a distal portion The outer diameter of shaft 1504 may gradually decrease along the length from a proximal end to a distal end of shaft 1504 Alternatively, the outer diameter of shaft may abruptly change at any desired location However, shaft 1504 may have a substantially constant outer diameter along the entire length of shaft 1504

[0211] In some embodiments, an outer surface of shaft 1504 may be provided with a plurality of markings or indicators (not shown) For example, in some embodiments, an outer surface of shaft 1504 may include a plurality of black ink markings every 1 centimeter for approximately 15 centimeters near the proximal end of shaft 1504 The markings may correlate with the length of, for example, access sheath 1000, and may be used as a reference during insertion of catheter 1500 A distal end 1504d of shaft 1504 may extend over an adapter (151Of in Fig 15E) The adapter may include any suitable configuration For example, the adapter 151Of may be made of stainless steel Furthermore, the adapter 151Of may be secured to distal end 1504d by any suitable means

[0212] Needle lumen shaft 1506 may include any suitable configuration For example, shaft 1506 may have a length of approximately 14 inches, an inner diameter of approximately 0 1 inches, and an outer diameter of approximately 0 12 inches Furthermore, shaft 1506 may be made of any suitable material For example, some embodiments of shaft 1506 may be made of 4OD PEBAX In addition, some embodiments of shaft 1506 may include a suitable reinforcement mechanism reinforcing the shaft 1506 For example, shaft 1506 may be reinforced with a stainless steel flat ribbon coil

[0213] Needle lumen shaft 1506 may include one or more coatings and/or coverings provided on an internal and/or external surface of shaft 1506 For example, in some embodiments, an internal surface (e g , surface 1506a) may be provided with a PTFE liner In other embodiments, an external surface of shaft 1506 may be provided with a lubricious coating

[0214] As noted above, a proximal portion 1506b of shaft 1506 may be bonded with, for example, cyanoacrylate adhesive, to a hypotube (not shown) extending from manifold 1502 The shaft 1506 may be maintained in close proximity to vacuum shaft 1504 by any suitable means For example, shaft 1506 may be attached to shaft 1504 with reflowed (this is the material between 1504 and 1506 in Figure 15B) 25D PEBAX, so as to maintain flexibility

[0215] Needle lumen steering mechanism 1508 may include any suitable mechanism for steering shaft operation inside shaft 1506 Mechanism 1508 may be configured to traverse the entire length of shaft 1506, and may include at least three distinct segments These segments may include proximal segment 1508a, middle segment 1508b, and distal segment 1508c, as shown in Fig 15C

[0216] Proximal segment 1508a may include any suitable configuration For example, proximal segment 1508a may include a length of approximately 9 inches Additionally, proximal segment 1508a my be constructed from a stainless steel hypotube 1508d Hypotube 1508d may include any suitable configuration For example, hypotube 1508d may include an inner diameter of 0 077 inches and an outer diameter of 0 095 inches

[0217] A proximal end of hypotube 1508d may be secured to a female luer by any suitable means, including, but not limited to, being bonded with an ultraviolet adhesive Hypotube 1508d may be configured to be passed through manifold 1502 and Touhy 1503, and traverse into a proximal portion of shaft 1506 In some embodiments, an inner portion of hypotube 1508d may be provided with a drive cable (not shown) The drive cable may be any suitable drive cable and may be configured to extend from a proximal end of hypotube 1508 through the entire middle segment 1508b of needle lumen steering mechanism 1508 The hypotube 1508d may be connected, by, for example, being bonded with epoxy, to the drive cable, near a proximal end of hypotube 1508d

[0218] The middle segment 1508b of mechanism 1508 may include any suitable configuration For example, middle segment 1508b may have a length of approximately 15 inches, an inner diameter of approximately 0 047 inches, and an outer diameter of approximately 0 073 inches Furthermore, middle segment 1508b may include a drive cable that may be constructed of a triple layer, flat coiled stainless steel ribbon wire (not shown) having an outer layer made of, for example, 55D PEBAX A distal end of the ribbon wire may be secured to a distal segment 1508c by any suitable means, such as, for example, welding

[0219] Distal segment 1508c may include a curved stainless steel hypotube 1508e having any suitable configuration For example, hypotube 1508e may include a length of approximately 0 67 inches, an inner diameter of approximately 0 053 inches, and an outer diameter of approximately 0 065 inches Furthermore, in some embodiments, hypotube 1508e may include a stainless steel ball (151Oe in Fig 15D) welded around the outer distal portion of hypotube 1508e (creating the inner solid marker discussed below in greater detail)

[0220] With references now to Figs 15A, 15D, and 15E, there are depicted various views of distal cup 1510 Cup 1510 may be made of any suitable material, including, but not limited to, polycarbonate Furthermore, cup 1510 may include any suitable configuration For example, in the disclosed embodiment, cup 1510 may include a diameter of approximately 0 5 inches, and may include at least three polycarbonate half spheres These half spheres may include inner sphere 1510a, middle sphere 1510b, and outer sphere 1510c Furthermore, some embodiments of cup 1510 may include a sighting ring 151 Od [0221 ] With specific reference to Fig 15E, inner sphere 1510a may be bonded with, for example, ultraviolet adhesive, to a distal portion of the needle lumen steering mechanism 1508, just proximal of stainless steel ball 151Oe The middle sphere (or vacuum sphere) 151 Ob may be disposed over inner sphere 151 Oa on the needle lumen steering mechanism 1508, and may be bonded with, for example, ultraviolet adhesive to stainless steel adapter 151Of at the distal end of vacuum shaft 1504 Outer sphere 1510c may be bonded with, for example, ultraviolet adhesive to the steering mechanism 1508, proximal to middle sphere 1508b, as depicted in Fig 15E

[0222] The inner and outer spheres 1510a and 1510c may be connected to the needle lumen control feature and may sandwich middle sphere 1510b, which may be connected to vacuum shaft 1504 The middle sphere 1510b may be stabilized in position during, for example, an implantation procedure, via vacuum shaft 1504 The inner and outer spheres 1510a and 1510c may facilitate movement of the needle shaft 1506, in order to position the sighting ring 151 Od around the inner solid marker (e g , ball 151 Oe) The sighting ring 151Od may include any suitable configuration For example, the sighting ring 1510d may have a thickness of approximately 0 025 inches and a diameter of approximately 0 25 inches Furthermore, sighting ring 151Od may be secured to an outer surface of outer sphere 1510c by any suitable means For example, sighting ring 151Od may be bonded with ultraviolet adhesive to outer sphere 1510c

[0223] Distal cup 1510 of catheter 1500 may be secured to the epicardial surface of heart H by applying vacuum to the vacuum port 1502b of manifold 1502 As will be discussed in greater detail below, advancing and retracting, along with twisting the proximal needle lumen steering mechanism 1508 in either direction, may rotate the distal cup 1510 such that the ball 151Oe is centered in the ring 151Od under fluoroscopic visualization Alignment of the ball 151Oe and ring 151Od features may aid in providing proper needle trajectory from the needle lumen of the catheter 1500 through the myocardium of heart H Once proper trajectory is achieved, tightening the Touhy may lock the needle lumen steering mechanism 1508 in position [0224] Turning now to Figs 16A-16C, there is depicted an exemplary embodiment of anterior sighting catheter 1600, in accordance with the principles of this disclosure Anterior sighting catheter 1600 may be configured to facilitate the identification of the proper epicardial location for the placement of anterior anchoring member 14 and introduction of anterior needle and snare (discussed below in greater detail)

[0225] Anterior sighting catheter 1600 may include any suitable configuration to achieve the desired purposes For example, anterior sighting catheter 1600 may include a length of approximately 23 inches Furthermore, anterior sighting catheter 1600 may have substantially similar components as posterior sighting catheter 1500 For example, the proximal portions of catheters 1500 and 1600 may be substantially the same However, as discussed below, the vacuum shaft 1604 of anterior sighting catheter 1600 may be shorter than shaft 1504 in catheter 1500, and may contain a shapeable distal end

[0226] With specific reference to Fig 16A, catheter 1600 may include a vacuum manifold 1602, a vacuum shaft 1604, a needle shaft 1606, a needle lumen steering mechanism 1608, and a distal cup 1610

[0227] Vacuum shaft 1604 may include any suitable configuration For example, shaft 1604 may include a length of approximately 15 inches, and may be constructed of similar materials as shaft 1504 In particular, the proximal portion of shaft 1604 may be constructed of the same PEBAX shaft material as shaft 1504, ranging in durometers (proximal to distal) from 7OD to 4OD, and may be reinforced with a stainless steel braid (not shown) Furthermore, like shaft 1504, shaft 1604 may contain two of the same stainless steel stiffening wires (1504c in Fig 15B), 0 013 inches in diameter, embedded in the PEBAX material

[0228] The inner and outer diameters of shaft 1604 may be substantially similar to those of shaft 1504 Similarly, an outer surface of shaft 1604 may be provided with markings every one centimeter for approximately 10 centimeters near a proximal end of shaft 1604 Like the posterior sighting catheter 1500, the markings may correlate with the length of access sheath 1000, and may be used as a reference during insertion of catheter 1600 In some embodiments, the markings on catheter 1600 may be the same distance from the center distal needle lumen markings on the ICE delivery catheter 1400 as they are from the distal stabilization vacuum cup 1406

[0229] Turning now to Figs 16B and 16C, the distal portion of shaft 1604, unlike shaft 1504, may include a hypotube 1620 inserted into the 4OD PEBAX shaft material Hypotube 1620 may be connected to a distal end of shaft 1604 by any suitable means For example, hypotube 1620 may be heat reflowed to the distal end of shaft 1604 Hypotube 1620 may include any suitable configuration For example, hypotube 1620 may include a length of approximately 2 inches Furthermore, hypotube 1620 may be configured to be malleable In particular, it is contemplated that embodiments of hypotube 1620 may include a plurality of slots 1621 along a portion of hypotube 1620 For example, slots 1621 may be disposed on approximately the distalmost 1 inch of hypotube 1620 The malleable segment of hypotube 1620 may facilitate proper positioning of catheter 1600 during the implantation procedures described in greater detail below Additionally, some embodiments of hypotube 1620 may include a covering made of, for example, 25D PEBAX, extending over hypotube 1620

[0230] Needle shaft 1606 of catheter 1600 may be similar to needle shaft 1506, but may be shorter in length, larger in diameter, and configured of slightly differing materials than shaft 1506 For example, needle shaft 1606 may have a length of approximately 14 inches Furthermore, embodiments of shaft 1606 may include a proximal hypotube 1606b and a distal shaft 1606a The proximal hypotube 1606b may have any suitable configuration For example, the proximal hypotube 1606b may have a length of approximately 5 inches Furthermore, proximal hypotube 1606b may have similar inner and outer diameters as the posterior sighting catheter 1500 In some embodiments, a proximal end of the hypotube 1606b may be connected to manifold in a manner substantially similar to that utilized in connection with catheter 1500 A distal end of hypotube 1606b may be operably connected to distal shaft 1606a by any suitable means For example, hypotube 1606b may be bonded with cyanoacrylate adhesive to distal shaft 1606a Distal shaft 1606a may include any suitable configuration For example, distal shaft 1606a may include a length of approximately 9 inches, an inner diameter of approximately 0 124 inches, and an outer diameter of approximately 0 134 inches

[0231] Furthermore, needle shaft 1606 may be made of any suitable material For example, needle shaft 1606 may be made from 55D PEBAX and may be reinforced by a stainless steel braid with a PTFE liner

[0232] Like needle shaft 1506, needle shaft 1606 may be maintained in close proximity to vacuum shaft 1604 by, for example, a needle lumen steering mechanism 1608 Needle lumen steering mechanism 1608 may be substantially similar to needle lumen steering mechanism 1508 in that mechanism 1608 utilizes similar or same materials for each of the proximal, middle, and distal segments However, for mechanism 1608, the dimensions for each of the segments may be modified

[0233] In particular, a proximal segment of mechanism 1608 may comprise a stainless steel hypotube (not shown) and may include a length of approximately 8 inches, an inner diameter of approximately 0 1 inches, and an outer diameter of approximately 0 12 inches A proximal end of the hypotube may be bonded with ultraviolet adhesive to a hub and an inner lumen (not shown) of the hypotube may contain a drive cable that may extend from a proximal end of the hypotube through the entire middle segment of mechanism 1608 The hypotube may be bonded with, for example, epoxy to the drive cable, near the proximal end of the hypotube

[0234] The middle segment of mechanism 1608 may include a length of approximately 12 inches, an inner diameter of approximately 0 7 inches, and an outer diameter of 0 1 inches Furthermore middle segment of mechanism 1608 may include a drive cable that may be constructed from a triple layer, flat coiled stainless steel ribbon wire and may include a 55D PEBAX outer layer In some embodiments, a distal end of the ribbon wire may be welded to a distal portion of mechanism 1608

[0235] The distal segment of mechanism 1608 may be substantially similar to that of mechanism 1508 For example, the distal segment may include a curved stainless steel hypotube (not numbered) having a length of approximately 0 75 inches, an inner diameter of approximately 0 072 inches, and an outer diameter of approximately 0 083 inches The hypotube may include a stainless steel ball, having a diameter of approximately 0 156 inches, connected by, for example, welding, around an outer distal portion of the tube (creating what is referred to herein as an inner solid marker during the sight identification phases discussed below)

[0236] The distal cup 1610 of catheter 1600 may include substantially the same outer diameter as the cup 1510 of catheter 1500 Furthermore, cup 1610 may be comprised of substantially similar polycarbonate spheres and a similar sighting ring component, as discussed in connection with cup 1510 In some embodiments, a difference between the anterior sighting catheter 1600 and posterior sighting catheter 1500 may include the larger size opening necessary to facilitate placement of the inner and outer half spheres over the needle lumen control mechanism 1608 of anterior sighting catheter 1600

[0237] Device Implantation Tools

[0238] Turning now to Figs 17A and 17B, there is illustrated an embodiment of posterior needle 1700, in accordance with the principles of the present disclosure Needle 1700 may be configured to navigate through the needle lumen steering mechanism 1508 of posterior sighting catheter 1500 and subsequently through the myocardium of the left ventricle of heart H In some embodiments, needle 1700 may include a needle tube 1702 and a stylet 1704, as discussed in greater detail below

[0239] Needle 1700 may include any suitable configuration For example, needle 1700 may include a length of approximately 70 inches In some embodiments, however, needle tube 1702 may be configured to be slightly shorter in length than stylet 1704 As shown in Fig 17A, needle tube 1702 may include a proximal hub 1706, a strain relief 1708, a shaft 1710, and a distal tip 1712 Proximal hub 1706 may include any suitable configuration For example, hub 1706 may include a female luer that may be bonded with, for example, ultraviolet adhesive, to shaft 1710 Strain relief 1708 may also include any suitable configuration For example, strain relief 1708 may have a length of approximately 1 5 inches Strain relief 1708 may be made of any suitable material, such as, for example, polyolefin In some embodiments, strain relief 1708 may be bonded with, for example, cyanoacrylate adhesive, over an outer distal portion of hub 1706 and outer proximal portion of shaft 1710

[0240] Shaft 1710 may include any suitable tube having a lumen (1710a in Fig 17B) therein Although the depicted embodiment of shaft 1710 is disclosed having one lumen, shaft 1710 may include a greater or lesser number of lumens as desired Shaft

1710 may be made from any suitable material For example, shaft 1710 may include a 72D PEBAX outer layer tube that may be reinforced with a flat tungsten ribbon wire

1711 Furthermore, shaft 1710 may include any suitable configuration For example, shaft 1710 may include an inner diameter of approximately 0 017 inches and an outer diameter of approximately 0 042 inches

[0241] With specific reference to Fig 17B, there is depicted an exemplary distal segment of shaft 1710 with stylet 1704 inserted within lumen 1710a As shown in Fig 17B, a distal portion of 1710, in some embodiments, may be provided with a distal tip 1714 defining a lumen 1714a therein Tip 1714 may include any suitable configuration For example, tip 1714 may include a length of approximately 0 4 inches, an inner diameter of approximately 0 015 inches, and an outer diameter of approximately 0 039 inches at a proximal end of tip 1714 While the outer diameter of tip 1714 at a distal end of tip 1714 may be the same as the diameter of the proximal end, it is contemplated that, in at least some embodiments, the outer diameter of tip 1714 may taper toward the distal end with a slight increase at the distalmost end Furthermore, tip 1714 may be made of any suitable material For example, tip 1714 may be made of a 50% tungsten loaded, 72D PEBAX material

[0242] In some embodiments, an outer surface of shaft 1710 may be provided with a plurality of indicators or markings For example, in the disclosed embodiment, an outer surface of shaft 1710 may include a plurality of distally disposed white marks 1718 disposed every centimeter for approximately 10 centimeters, approximately 27 centimeters from tip 1714 In addition, shaft 1710 may include a plurality of proximally disposed white marks 1720 every one centimeter extending four centimeters, approximately two inches from a proximal end of shaft 1710. It is contemplated that the distally disposed marks 1718 may be utilized as reference for insertion depth during an implantation procedure, and the proximally disposed marks 1720 may be utilized to identify the posterior end of shaft 1710 once the shaft creates a through lumen across a patient's heart and exits on the anterior side, as will be discussed in greater detail below.

[0243] Stylet 1704 may include any suitable configuration to achieve the desired purpose of puncturing a myocardial wall of a patient's heart. In some embodiments, stylet 1704 may include a wire 1704b having sharp, pointed distal tip 1704a. Wire 1704b may include any suitable configuration. For example, wire 1704b may include a generally circular cross-sectional area. Wire 1704b may have a maximum outer diameter of approximately 0.014 inches. Furthermore, wire 1704b may be made of any suitable material. In the disclosed embodiment, wire 1704b may be made of nitinol. As shown in Fig. 17A, a proximal end of stylet 1704 may be attached to a male luer 1704c by any suitable means. For example, luer 1704c may be attached to stylet 1704 with ultraviolet adhesive. Male luer 1704c may be configured to mechanically interface with female luer of hub 1706 of shaft 1710.

[0244] In some embodiments, needle 1700 may include one or more coatings and/or coverings disposed over any suitable portion of needle 1700. For example, a hydrophilic coating may be disposed on an exterior portion of shaft 1710 beginning from, for example, strain relief 1708 and extending over the distal ends of shaft 1710 and stylet 1704.

[0245] Turning now to Fig. 18, there is depicted a distal portion of anterior needle 1800. Needle 1800 may be substantially similar to needle 1700. Needle 1800 may include a shaft 1810 having a lumen 1810a and a stylet 1804 disposed therein. Needle 1800 may be configured to navigate through the needle lumen steering mechanism 1608 of anterior sighting catheter 1600 and through myocardial structures of heart H. Needle 1800 may also provide a passage for snare 1900 (discussed in greater detail below) to be delivered into the left ventricle LV of heart H Although needle 1800 may be substantially similar to needle 1700, needle 1800 may differ in a number of ways For example, needle 1800 may have a larger diameter shaft 1810 and may be shorter in length than needle 1700

[0246] Like needle 1700, needle 1800 may include any suitable configuration In particular, needle 1800 may include a proximal hub (not shown), a strain relief (not shown), a shaft 1810, and a distal tip 1814, and may be constructed from the same or substantially similar materials as needle 1700 However, needle 1800 may include a length of approximately 30 inches In addition, shaft 1810 may include an inner diameter of approximately 0 04 inches and an outer diameter of approximately 0 053 inches, with the outer diameter, in some embodiments, increasing slightly at the distal tip 1814 Furthermore, it is contemplated than in some embodiments, an outer surface of needle 1800 may be provided with a plurality of markings and/or indicators (not shown) For example, an outer surface of shaft 1810 may be provided with a plurality of white marks approximately 22 inches from the distal tip 1814 The white marks may be provided at one centimeter intervals for approximately 10 centimeters It is contemplated that the marks may be utilized as a reference for insertion depth during implantation procedures

[0247] With renewed reference to Fig 18, stylet 1804 may be slightly different than stylet 1704 For example, rather than being a solid nitinol wire, stylet 1804 may include a stainless steel wire coil 1804a disposed over the solid nitinol core wire 1804b having a maximum outer diameter of approximately 0 017 inches Coil 1804a may include any suitable configuration For example, coil 1804a may extend for approximately 29 inches from the proximal end of core wire 1804b towards the distal tip Coil 1804a may include an outer diameter of approximately 0 039 inches In some embodiments, the proximal ends of coil 1804a and wire 1804b may be secured to a male luer by any suitable means, such as, for example, adhesive bonding

[0248] Furthermore, in some embodiments, stylet 1804 may include a PEBAX layer 1804c disposed over a distal portion of wire 1804 Layer 1804c may include, for example, 50% tungsten loaded PEBAX Furthermore, layer 1804c may be located approximately 0 2 inches from a distal tip of core wire 1804b, and may include an outer diameter of 0 04 inches, which may transition to the core wire 1804b at the distal tip, as depicted in Fig 18

[0249] Like needle 1700, needle 1800 may include one or more coatings and/or coverings disposed over any suitable portion of needle 1800 For example, a hydrophilic coating may be disposed on a distal half of needle 1800

[0250] Turning now to Figs 19A-19C, there is depicted an embodiment of a snare 1900, in accordance with the principles of the present disclosure Snare 1900 may be configured to capture needle 1700 once deployed in the left ventricular space of a patient A shown in Figs 19A-19B, snare 1900 may include a distal three-loop design 1910, a PEBAX segment 1920, and a proximal core wire 1930

[0251] As shown in Figs 19A and 19B, the distal three-loop design 1910 may include three loops 1911 , 1912, and 1913 The loops 1911-1913 may be fabricated from any suitable bio-compatible wire For example, each of loops 1911-1913 may be constructed from a 0 006 inch diameter solid nitinol wire When fully expanded, as shown in Fig 19B, snare 1900 may have a diameter of approximately 1 25 inches To facilitate visualization of loops 1911 -1913, loops 1911-1913 may be provided with one or more radiopaque or sonoreflective features and/or markers For example, it is contemplated that loops 1911-1913 may be wrapped with platinum/indium coils to enhance visibility of loops 1911-1913

[0252] With specific reference to Fig 19C, there is depicted a collet (sieve) 1940 for orienting loops 1911 -1913 Collet 1940 may include any suitable configuration For example, collet 1940 may include a thickness of 0 030 inches and diameter of 0 030 inches Furthermore, collet 1940 may include a centrally disposed through hole 1941 Collet 1940 may further include a plurality of through holes 1942 radially disposed and equally spaced about central through hole 1941 Each of holes 1942 and 1941 may include a diameter of approximately 0 0075 inches In use, each nitinol loop wire may be passed through two of through holes 1942 to create the three-loop design discussed above

[0253] With reference now to Figs 19A and 19C, core wire 1930 may include any suitable configuration For example, core wire 1930 may include a length of approximately 45 inches and a diameter of approximately 0 017 inches Additionally, a distal portion (not shown) of core wire 1930 may be ground to a diameter (e g , a diameter less than 0 0075 inches) so that the distal portion of core wire 1930 may traverse the central through hole 1941 of collet 1940 Core wire 1930 may be secured to collet 1940 by any suitable means For example, a distal end of core wire may be provided with a welded ball (not shown) configured to maintain collet 1940 on core wire 1930

[0254] The wires that make up loops 1911-1913 may be coiled about core wire 1930 on the proximal side of collet 1940 The transition of the loop wires to the coil about core wire 1930 may be covered by two PEBAX layers The first PEBAX layer may be disposed near collet 1940 and may have a length of approximately 0 2 inches The second PEBAX layer may include a length of approximately 1 3 inches and may be utilized to cover the proximal ends of the wires that make up loops 1911-1913

[0255] In order to facilitate insertion of snare 1900 into shaft 1810 of needle 1800, a snare introducer (not shown) may be pre-loaded onto the snare 1900 The snare introducer may include any suitable configuration to achieve the desired purpose For example, the introducer may include a stainless steel hypotube having a length of approximately 6 inches, an inner diameter of approximately 0 046 inches, and an outer diameter of 0 059 inches In some embodiments, a male luer (not shown) may be bonded to the hypotube with epoxy approximately 0 365 inches from the proximal end of the hypotube

[0256] Furthermore, in some embodiments, snare 1900 may be provided with a polycarbonate removable torque component (not shown) to facilitate movement of snare 1900 once it has been deployed The removable torque component may be secured onto core wire 1930 by any suitable means known in the art, such as, for example, a screw tightening mechanism (not shown)

[0257] Turning now to Fig 20, there is depicted an embodiment of an anterior tension member protector 2000 Protector 2000 may include a single lumen catheter that is designed to cover a distal end of the tension member 12 within the confines of access sheath 1000 Protector 2000 may include a distal tip 2010, a catheter shaft 2020, and a proximal connector 2030

[0258] The distal tip 2010 may include any suitable distal tip having any suitable configuration For example, tip 2010 may include a polycarbonate tube having a length of 0 275 inches Additionally, tip 2010 may include an inner diameter that transitions from approximately 0 129 inches at the proximal end to approximately 0 09 inches, 0 15 inches from the proximal end Additionally, as shown in Fig 20, a proximal end of tip 2010 may be secured to catheter shaft 2020 by any suitable means, including, but not limited to, bonding with ultraviolet adhesive A distal end of tip 2010 may be provided with an outward radius

[0259] Catheter shaft 2020, as alluded to above, may include a single lumen (not shown) However, those of ordinary skill in the art will readily recognize that shaft 2020 may include a greater or lesser number of lumens as desired Shaft 2020 may include any suitable configuration For example, shaft 2020 may include a length of approximately 14 inches, an inner diameter of approximately 0 1 1 inches, and an outer diameter of approximately 0 12 inches Furthermore, shaft 2020 may be constructed from any suitable, bio-compatible materials For example, shaft 2020 may be made of a 20% Barium loaded PEBAX tube Additionally, shaft 2020 may be provided with any suitable reinforcement mechanism For example, shaft 2020 may be reinforced with a stainless steel braid In some embodiments, shaft 2020 may be provided with one or more coatings, coverings, and/or linings For example, shaft 2020 may be lined with an inner ePTFE layer

[0260] Shaft 2020 may include a marker band 2021 Band 2021 may be configured to be radiopaque and/or sonoreflective as desired The band 2021 may include any suitable configuration For example, band 2021 may include a length of approximately 0 225 inches and may be made of, for example, stainless steel Band 2021 may be secured to shaft 2020 by any suitable means, including, but not limited to, bonding with an ultraviolet adhesive

[0261] Shaft 2020 may further include a white mark 2022 at approximately a mid- segment of shaft 2020 The mark 2022 may be configured to indicate when the distal tip of protector 2000 is at the distal tip of access sheath 1000 Furthermore, a proximal portion of shaft 2020 may be provided with a polyolefin heat shrink wrap (not shown) for identification purposes It is contemplated the heat shrink wrap may be provided with identifying marks, such as, for example, alpha-numeric labels A proximal end of shaft 2020 may be connected to a suitable connector 2030 by any suitable means, including, but not limited to, bonding with an ultraviolet adhesive The connector 2030 may include an ABS female hub connector having a length of approximately 0 124 inches, an inner diameter of 0 120 inches, and a outer diameter of 0 255 inches

[0262] Devices for Sizing and Therapeutic Evaluation

[0263] Turning now to Fig 21 , there is depicted an exploded view of an exemplary embodiment of a sizing instrument 2100, in accordance with the principles of the present disclosure Instrument 2100 may be configured to adjust the length of tension member 12 to an appropriate length prior to deployment of staple 23 within anterior anchoring member 14 Embodiments of instrument 2100 may include a threaded rod 2110 disposed at a proximal end 2100a of instrument 2100 Rod 21 10 may be inserted into a guide block 2120 and a guide tube 2130 having a lumen 2130a therein Guide block 2120 may include any suitable spring-loaded component that may be configured to stabilize the rod 2110 in any desired location Guide block 2120 may be made of any suitable material, including, but not limited to, polycarbonate In some embodiments, guide tube 2130 may be provided (e g , printed) with a graduated scale on an external surface of guide tube 2130

[0264] Furthermore, a distal end 2130b of guide tube 2130 may include a collet assembly 2140 disposed therein Assembly 2140 may be secured within tube 2130 by any suitable means For example, assembly 2140 may be mechanically press-fit into tube Assembly 2140 may include a collet and a rod configured to be slidably disposed within tube 2130 Assembly 2140 may be secured to (e g , bonded with epoxy and threaded) a cone tip 2150 Cone tip 2150 may include any suitable configuration For example, tip 2150 may include a length of approximately 0 48 inches Furthermore, tip 2150 may be made of any suitable material, including, but not limited to, polycarbonate

[0265] In some embodiments, tip 2150, on a distal end, may be connected to an extension tube 2160 by any suitable means For example, tip 2150 may be bonded with epoxy to tube 2160 Tube 2160 may include any suitable extension tube and may include any suitable configuration For example, in some embodiments, tube 2160 may be reinforced with coiled wire, while in other embodiments, tube 2160 may include one or more lumens disposed therein Additionally, tube 2160 may include any suitable dimensions desired For example, tube 2160 may include a length of approximately 13 inches, an inner diameter of approximately 0 069 inches, and an outer diameter of approximately 0 125 inches Tube 2160 may be fabricated from any suitable material For example, tube 2160 may be made of a hytrel and polyolefin tube having an internal extension spring in some embodiments

[0266] Furthermore, tube 2160 may be provided with one or more marker bands 2161 disposed at any suitable location Marker bands 2161 may be made of stainless steel and may be secured to tube 2160 with an ultraviolet adhesive A distal portion of tube 2160 may include a tip 2170 Tip 2170 may include any suitable configuration For example, tip 2170 may include a length of approximately 0 333 inches Additionally, tip 2170 may be made of any suitable material, including, but not limited to, polycarbonate Tip 2170 may be secured to tube 2160 by any suitable means For example, tip 2170 may be bonded to tube 2160 with an ultraviolet adhesive

[0267] Turning now to Fig 22, there is depicted an exemplary embodiment of a cautery device 2200, in accordance with the principles of the present disclosure The device 2200 may include a high temperature, handheld cutting instrument that may be used to trim excess portion of tension member 12 once the staple 23 has been deployed in anterior anchoring member 14 Device 2200 may include a proximal handle 2210 having an actuator 2211 , a distal shaft 2220 having a length of approximately 5 inches, and a heating element 2230

[0268] Turning now to Fig 23, there is depicted an exemplary embodiment of a cautery guide 2300, in accordance with the principles of the present disclosure Cautery guide 2300 may include any configuration for introducing device 2200 to an appropriate tension member 12 location For example, in one embodiment, guide 2300 may include a handle 2310, a cap 2320, a tube 2330 having a lumen 2331 therein, and a tip 2340 The distal end of guide 2300 may include the tip 2340 Tip 2340 may include any suitable configuration For example, tip 2340 may include a length of approximately 1 13 inches and may be made of PEEK As shown in Fig 23, tip 2340 may have a substantially conical, tapered shape Tip 2340 may include a tension member lumen 2341 disposed therein Lumen 2341 may include any suitable configuration For example, in one embodiment, lumen 2341 may include a first portion (not shown) having a diameter of approximately 0 086 inches along the tapered portion of tip 2340 The first portion of lumen 2341 may lie in a plane substantially parallel to a longitudinal axis of guide 2300 Lumen 2341 may include a second portion (not shown) connected to the first portion The second portion may be disposed substantially perpendicular to the first portion, and may have an opening 2342 disposed approximately 0 2 inches distally from the proximal end of tip 2340 Additionally, the proximal end of tip 2340 may include a hollow lumen (not shown) The hollow lumen may include any suitable configuration For example, the hollow lumen may include a width of approximately 0 07 inches, a length of approximately 0 17 inches, and a depth of approximately 0 425 inches (into the tip)

[0269] In some embodiments, the hollow lumen may be configured to be compatible with a distal (heating) end of cautery device 2200 In other words, the hollow lumen may be configured to withstand pre-determined amounts of heat energy Tip 2340 may be connected to a distal portion of tube 2330 by any suitable means For example, tip 2340 may be bonded with an ultraviolet adhesive to tube 2330 [0270] Tube 2330 may include any suitable configuration For example, tube 2330 may include a length of approximately 4 inches, an inner diameter of approximately 0 313 inches, and an outer diameter of approximately 0 375 inches Lumen 2331 may have any suitable configuration for receiving a distal portion of device 2200 Furthermore, tube 2330 may be made of any suitable material, such as, for example, nylon A proximal end of tube 2330 may be bonded to a cap 2320 molded from PEEK As shown in Fig 23, cap 2320 may include a through hole 2321 configured to interface with a portion of device 2200

[0271] In some embodiments, a stainless steel hypotube 2311 may be bonded with an adhesive to a proximal side of cap 2320 Hypotube 2311 may include any suitable configuration For example, hypotube 2311 may include a length of approximately 5 5 inches, an inner diameter of 0 106 inches, and an outer diameter of 0 134 inches A proximal end of hypotube 231 1 may be bonded with an epoxy to any suitable PEEK fitting 2312 Fitting 2312 may have any suitable configuration For example, fitting 2312 may include a length of approximately 1 inch Together, hypotube 2311 and fitting 2312 may define a handle 2310 of guide 2300

[0272] Description of exemplary implantation procedures

[0273] As alluded to above, medical device 10 may be configured to be implanted on a patient's heart H Medical device 10 may be configured to be advanced to heart H by any suitable means In one embodiment, medical device 10, and its related components, may be delivered to heart H via a percutaneous subxiphoid approach

[0274] Device 10 may be configured to be positioned transventricularly, between a point apical to the right ventricular outflow tract and approximately two centimeters medial to the inter-ventricular groove (anterior position) and a point on the posterior LV wall directly between the papillary muscles and two to three centimeters apical from the mitral valve annulus, such that the superior contact zone 16a of the posterior anchoring member 16 may rest at the level of the annulus (posterior position)

[0275] As noted above, medical device 10 may be implanted percutaneously via a subxiphoid approach Percutaneous implantation of the medical device 10 may be performed by first entering the mediastinal space of the thoracic cavity through a right xiphoid skin incision Access to the pericardial space may be subsequently gained using the tools disclosed herein and ancillary commercially available devices and equipment Actual placement of the implant may be achieved with the use of the specially designed catheters disclosed herein and with the aid of fluoroscopic (fluoro) and echocardiography (echo) guidance

[0276] The entire implantation procedure for medical device 10 may be conducted in four distinct phases 1 ) Percutaneous Pericardial Access, 2) Site Identification, 3) Device Implantation, and 4) Sizing and Therapeutic Evaluation During the Percutaneous Pericardial Access phase, a secure access pathway may be created for device delivery from outside a patient's chest wall to inside the pericardial space using fluoroscopic guidance Optimum locations for the anterior and posterior anchoring members 14 and 16 may be identified during the Site Identification phase (discussed in greater detail below) using fluoroscopic and echo guidance During the Device Implantation phase, a transventπcular connection may be first created using fluoroscopic guidance, and the medical device 10 may be then delivered over this connection to the previously identified locations Medical device 10 then may be sized during the Sizing and Therapeutic Evaluation phase under transesophageal echo (TEE) guidance, and the device may then be deployed A detailed description of each phase is provided in the following sections

[0277] Description of Percutaneous Pericardial Access Phase

[0278] Steps within the pericardial access phase are shown and described in Section 3 3 1 1 of the attached Appendix A That description, including Figure 3-67 and 3-68, is incorporated herein in its entirety

[0279] Once basic pre-operation patient management and preparation has occurred and the general implant location has been determined with fluoro and echo evaluations, a small incision may be made in the subxiphoid region with any suitable standard, commercially available equipment The introducer 700 may be advanced under fluoroscopic guidance through the incision toward the location of the intended pericardial access site

[0280] Once the introducer 700 is determined to be in the desired position, the obturator 703 may be removed from tube 701 The needle 800 may then be inserted through the tube 701 of introducer 700 to the pericardium and advanced, under fluoroscopic visualization, until a tactile "pop" is felt The "pop" is a signal to the physician that the tip of the needle 800 has pierced the patient's pericardium and is now engaged with the pericardium by the "gap" and "stop" on the distal end of the needle Steady pull-back traction may be applied to the device with concomitant injection of contrast media through the Y-adapter 807 to verify intrapeπcardial access

[0281] Once the pericardial space is accessed by the needle 800, guidewire 900 may be advanced under fluoroscopic visualization into the pericardial space, and the needle 800 and introducer 700 may be removed A standard, commercially available, wire exchange tool may be utilized to exchange the guidewire 900 for a standard 0 035 inches guidewire A standard, commercially available, 11 F introducer (ι e , an 1 1 French introducer) (minimum 23 cm length) may then be advanced over the 0 035 inches guidewire and dilator removed A non-compliant, 20-25 mm x 6 cm, commercially available balloon catheter, with a minimum rated burst pressure of 4 atm, may then be advanced through the 11 F introducer into the pericardial opening Upon retraction of the 1 1 F introducer, the balloon may be inflated to dilate the pericardium, mediastinal, and subdermal layers of heart H and may then be removed, with the 0 035 inches guidewire left in position The dilator 1020 of the access sheath 1000 may be advanced over the 0 035 inches guidewire, into the pericardial opening for additional dilation of the pericardial access site The dilator 1020 may then be retracted, leaving the 0 035 inches guidewire in position

[0282] Once the access pathway is dilated, the access sheath 1000 (with dilator 1020) may be advanced through the opening until the lip 1012b ( i e , pericardial securement feature) of the sheath is engaged with the pericardial opening Next, the dilator 1020 and 0 035 inches guidewire may be removed once the access sheath 1000 has been secured in location with the securement clamp 1030 This provides entrance to the pericardial space for the rest of the implantation procedure Subsequently, the catheter securement clip 1100 may be attached to the proximal end of the sheath 1000, to, for example, aid in stabilization of the devices used in the subsequent implantation phases

[0283] Description of Site Identification Phase

[0284] Steps within the site identification phase are shown and described in Section 3 3 1 2 of the attached Appendix A That description, including Figures 3-69 through 3-76, is incorporated herein in its entirety

[0285] Once access into the pericardial space is secured, AP (relative to the heart) fluoroscopic views and left-sided angiography and RV grams may be used to identify the approximate implant location The vacuuming tubing set 1200 and two vacuum lines 1300 may be connected to an institutional or other vacuum source Next, the ICE delivery catheter 1400 may be connected to one of the vacuum lines 1300 (e g , the anteriorly disposed line) and a commercially available Acuson Acunav™ Intra Cardiac Echo (ICE) imaging catheter or other suitable imaging catheter may be advanced into the ICE delivery catheter 1400

[0286] The ICE delivery catheter 1400 may be inserted into the pericardial space and advanced to the desired anterior anchoring member 14 location on the epicardial surface of the heart H The vacuum stabilization cup 1406 of the ICE delivery catheter may then be secured by vacuum to the desired epicardial location This allows short axis echo imaging to confirm the anticipated position of anterior anchoring member 14 Adjustments in position are made if necessary Figures 3-69 and 3-70 of the attached Appendix A illustrate the location of the ICE Delivery Catheter (and ICE imaging catheter) and an example of the short axis image obtained from the ICE imaging catheter Next, the proximal end of the ICE delivery catheter 1400 may be placed in one of the clips 1106/1107 (e g , the clip designated anterior) of the clip 1 100

[0287] The desired location of the posterior anchoring member 16 may then be identified using an AP (relative to the heart) fluoroscopic view and a left-sided angiogram The posterior location is identified as approximately the middle of the posterior LV wall and two to three centimeters apical to the left circumflex coronary artery The posterior sighting catheter 1500 may be connected with one of the vacuum lines 1300 and may be advanced into the pericardial space to the approximate posterior anchoring member 16 location

[0288] The distal cup 1510 of the posterior sighting catheter 1500 may be secured to the epicardial surface of the heart by applying vacuum The proximal portion of the posterior sighting catheter 1500 is placed in one of clips 1106/1107 (e g , the clip designated to receive posterior delivery devices) of the catheter securement clip 1 100 Using ICE images, fluoroscopic evaluations, and TEE, the distal cup 1510 of the posterior sighting catheter 1500 may be confirmed to be in the desired location of the posterior anchoring member 16 Any suitable adjustments in position may be made if necessary

[0289] The fluoroscopy camera may be oriented such that the ICE imaging catheter 1400 array may be superimposed on the posterior sighting catheter distal cup 1510 The location of the ICE Delivery Catheter 1400 is noted on fluoroscopy and is then replaced with the anterior sighting catheter 1600 such that the ball features of each of the anterior and posterior sighting catheters 1600 and 1500 may be superimposed upon each other

[0290] Position of the distal cup 1610 of the anterior sighting catheter 1600 may be stabilized by applying vacuum to the catheter The proximal portion of the anterior sighting catheter 1600 may be placed in the clip 1106/1107 holding anterior placement devices of the catheter securement clip 1100

[0291] Description of Device Implantation Phase

[0292] Steps within the device implantation phase are shown and described in Section 3 3 1 3 of the attached Appendix A That description, including Figure 3-77 through Figure 3-87, is incorporated herein in its entirety

[0293] The device implantation phase may be conducted under fluoroscopic visualization In order to ensure the proper orientation of the trajectories of needle lumen steering mechanism 1608/1508 of the anterior and posterior sighting catheters 1600 and 1500 in relation to each other, the balls (e g , 151Oe) and sighting rings (e g , 151Od) within the posterior and anterior distal cups are aligned under fluoroscopic visualization This is accomplished by effectively "aiming" one catheter at the other by aligning the ball within the sighting ring through manipulation of the distal needle lumen steering mechanisms of each catheter

[0294] The needle lumen steering mechanism 1608 may be adjusted on the anterior sighting catheter 1600 such that the inner solid marker (e g , ball 161Oe) may be centered in the sighting ring 161Od of the distal cup 1610 when visualized under fluoroscopic evaluation This indicates that the needle lumen steering mechanism 1608 of the anterior sighting catheter 1600 is directed at the posterior sighting catheter distal cup 1510 Once the sighting ring 161Od is centered around the ball 161Oe, the needle lumen steering mechanism 1608 of the anterior sighting catheter 1600 is considered to be "aimed" toward the posterior sighting catheter 1500

[0295] Next, the needle lumen steering mechanism 1508 may be adjusted on the posterior sighting catheter 1500 such that the ball in distal cup 1510 may be centered in the sighting ring of the distal cup 1510 when visualized under fluoroscopic evaluation Once the sighting ring of distal cup 1510 is centered around the ball in distal cup 1510, the needle lumen steering mechanism 1508 of the posterior sighting catheter 1500 is considered to be "aimed" toward the anterior sighting catheter 1600 Once proper positioning and alignment of the needle lumen steering mechanisms 1608 and 1508 of the anterior and posterior sighting catheters 1600 and 1500 are achieved, and confirmed via fluoroscopic visualization, the anterior needle 1800 may be advanced through the needle lumen of 1608 of the anterior sighting catheter 1600 The anterior needle 1800 may be advanced through the myocardium and into the left ventricle under fluoroscopic guidance Markers (e g , 1818/1820) on the anterior needle shaft 1810 may be utilized to assure that it is advanced the appropriate distance The anterior needle stylet 1804 may then be removed, leaving the anterior needle shaft 1810 in the left ventricle The snare 1900 may then be advanced through the shaft 1810 of the anterior needle 1800 and deployed in the left ventricle LV

[0296] Next, the posterior needle 1700 may be advanced through the needle lumen steering mechanism 1508 of the posterior sighting catheter 1500, through the myocardium and into the left ventricle LV under fluoroscopic guidance Once the posterior needle 1700 is located in the left ventricle LV, it may then be advanced into the snare 1900 Markers on the posterior needle shaft 1710 may be utilized to aid in identification of the appropriate insertion distance

[0297] Once the posterior needle 1700 is confirmed to be positioned within the snare 1900, the snare 1900 is collapsed and the posterior needle 1700 is captured The posterior needle stylet 1704 is removed, leaving the needle tube in place The snare 1900 is then further collapsed and pulled back into the anterior sighting catheter 1500, drawing the posterior needle tube into the needle lumen of the anterior sighting catheter 1500 The anterior sighting catheter 1500 is then removed from the patient, and the posterior sighting catheter 1500 is removed from the patient, leaving the posterior needle tube in place The posterior side of the needle shaft 1710 may be identified by the white marks described above The posterior side may then be placed in one of clips 1 106/1107 of the catheter securement clip 1100 The anterior side of the needle shaft 1710 may not contain white marks (or may contain marks discernible from the white marks of shaft 1810) and may be placed in the other of clips 1106/1107 of the catheter securement clip 1100 With the needle shaft in place, a lumen across the left ventricle is established through which the tension member 12 may be delivered

[0298] Next, the anterior tension member protector 2000 may be advanced over the anterior side of the needle shaft 1710 and may be placed in the clip holding the anterior side of the needle shaft 1710 The leader wire of the tension member 12 may be passed into the posterior side of the needle shaft 1710 The tension member 12 may be advanced from the posterior side until it is across the LV, while the needle shaft/leader wire is drawn from the anterior side The O-ring may then be removed from the insert 12a of the tension member 12 and the insert may be placed into the appropriate sized posterior anchoring member 16, which is attached to the posterior anchoring member delivery catheter 60 The posterior anchoring member 16 may then be advanced to the desired posterior location by orienting the posterior anchoring member 16 along the cardiac long axis and advancing the catheter 60 while pulling the tension member 12 from the anterior side

[0299] Once the posterior anchoring member 16 is confirmed in location, the proximal portion of the catheter 60 may be secured in the clip 1106/1107 holding posterior placement devices of the catheter securement clip 1100 The orientation of the posterior anchoring member 16 may be adjusted to ensure proper placement of the superior and inferior contact zones 16a and 16b of the posterior anchoring member 16 ICE imaging, TEE, and angiography may used to facilitate visualizing the necessary adjustments

[0300] Next, the protector 2000 and the tension member cover may be removed from the tension member 12, exposing the ePTFE surface The leader wire of the tension member 12 may then be threaded through the anterior anchoring member 14, which may be attached to the anterior anchoring member delivery catheter 30 The anterior anchoring member 14 (in its collapsed configuration) may then be advanced over the leader wire through the access sheath 1000 Upon exiting the access sheath 1000, the anterior anchoring member 14 may be expanded and rotated into the appropriate orientation for deployment Proper orientation of the anterior anchoring member 14 may be confirmed via fluoroscopic and TEE evaluations Once the anterior anchoring member 14 is placed in the desired location, the proximal portion of the catheter 30 may be placed in the clip 1 106/1107 holding anterior placement devices of the catheter securement clip 1 100

[0301 ] The leader wire of the tension member 12 may then be threaded into the distal tip of the sizing instrument 2100 until the sizing instrument 2100 rests atop the anterior anchoring member 14

[0302] Description of Sizing and Therapeutic Evaluation Phase [0303] Steps within the sizing and therapeutic evaluation phase are shown and described in Section 3 3 1 4 of the attached Appendix A That description is incorporated herein in its entirety

[0304] Once the sizing instrument 2100 is atop the anterior anchoring member 14 and all slack has been removed from the tension member 12, the length measurement on the sizing instrument may be noted as the "0%" level Utilizing the sizing instrument 2100 once again, medical device 10 may then be sized by cinching the tension member 12 in 5% increments, which shortens the distance between the posterior and anterior anchoring members Once the desired result has been obtained, as confirmed with TEE imaging, the staple 23 may be deployed within the anterior anchoring member 14 At this point, the sizing instrument 2100, various catheters (e g , 1400, 1500, 1600, etc ), and the access sheath 1000 may be removed from the patient, leaving only the tension member 12 exiting the incision

[0305] Next, the cautery guide 2300 may be inserted, over the tension member 12, until it rests atop the anterior anchoring member 14 The cautery device 2200 may then be inserted into the cautery guide 2300 and activated to sever excess portions of the tension member 12 from the anterior anchoring member 14 Once the excess portions are severed, the cautery guide 2300 and cautery device 2200 may be removed from the patient and the small epidermal incision may be repaired via standard surgical closure techniques

[0306] It will be apparent to those skilled in the art that various modifications and variations can be made to the systems and methods of the present disclosure without departing from the scope of the disclosure In addition, other embodiments will be apparent to those skilled in the art from the consideration of the specification and practice of the systems and methods disclosed herein It is intended that the specification and examples be considered as exemplary only, with a true scope of the disclosure being indicated by the following claims and their equivalents iCoapsys System Device Description

3.2.1 iCoapsys Device

The iCoapsys Device is an implant that consists of two epicardial pads (Posterior and Anterior) and a SubvaJvular Chord (reference Figure 3-1).

The epicardial pads are placed on the surface of the heart while the load-bearing Subvalvυlar Chord passes across the left ventricle (LV) to connect the pads. The implanted device is located apically relative to the mitral valve leaflets with the Subvalvυlar Chord passing between the papillary muscles on the posterior LV wall (reference Figure 3-2.)

One epicardial pad (Posterior Pad) consists of two interconnected heads (referred to as basal and apical) that are placed on the posterior wall of the heart The basal head of the Posterior Pad is placed at or near the level of the mitral valve annulus, while the apical head is placed lower on the wall of the LV. The second epicardial pad (Anterior Pad) is placed half-way between the left ventricular apex and the base of the left ventricle, medial to the left anterior descending artery near the inter-ventricular groove.

Using interventional instruments provided with the device and ancillary commercially available devices, the iCoapsys Device is percutaneously delivered and implanted in the desired location.

3.2.1.1 Posterior Pad

The Posterior Pad is made of polyether ether ketone (PEEK) material with polyester material over the elements that contact the epicardial surfaces of the heart. The polyester covering is sutured to the PEEK material. A platinum/iridium coil is threaded over a portion of the suture material to ensure that the head locations are visible under fluoroscopy. The head configuration (both basal and apical) of the iCoapsys Posterior Pad is a "D" shape, identical to one of the head configurations used in the Coapsys pad family. The pads are available in several sizes (2.0cm, 2.5cm, and 3.0cm), similar to the Coapsys. The size of the pad is determined by the distance from the midpoint (Subvalvular Chord attachment location) to the tip of the basal head. The iCoapsys Posterior Pad includes catheter attachment and detachment mechanisms that are explained in further detail in subsequent sections of this document. Figures 3-3 through 3-6 illustrate the iCoapsys Posterior Pad. Note: The Coapsys Posterior Pad is also depicted in the illustrations for reference purposes.

Figure 3-4: Posterior Pad Family (Pericardial View)

In order to facilitate percutaneous delivery, the Posterior Pad is attached to the distal end of a Posterior Pad Catheter (reference Figure 3-7). The Posterior Pad Catheter is used to guide the pad into position inside the pericardial space.

Figure 3-7: Posterior Pad Catheter

The Posterior Pad Catheter shaft is constructed of a single lumen tube that consists of a stainless steel braid encased in various durometers of PEBAX (polyether block amide) material. The tube has three distinct segments; proximal, mid, and distal. While the stainless steel braid extends the full length of the tube, each segment is constructed from a different durometer of the PEBAX material. The proximal segment is made using 70 durometer (D) PEBAX with an inner of 63D PEBAX. The mid segment is made using 55D PEBAX. The distal segment is made using 25D PEBAX. The approximate length for the proximal, mid, and distal segments are 12.5 inches, two inches, and 6.5 inches, respectively. The outer diameter (OD) of the shaft is approximately 0.230 inches and the inner diameter (ED) is 0.095 inches at the distal end and 0.125 inches at the proximal end. A stainless steel hypotube extends from the proximal catheter handle approximately 10 inches inside the catheter shaft towards the distal portion of the catheter. The ED of the hyporube is approximately 0.09 inches and the OD is approximately 0.125 inches. The distal portion of the shaft is pinned to the pad attachment mechanism with stainless steel pins and has an FEP (Fluorinated Ethylene-Propylene) heat shrink covering on the outside of the catheter. The proximal portion of the shaft (along with the inner stainless steel hypotυbe) is clamped into the urethane handle of the Posterior Pad Catheter.

The handle of the catheter is labeled "Posterior" and contains the control mechanisms necessary to position and release the Posterior Pad (reference Figure 3-8).

The steering lever mechanism is used to rotate the pad attachment mechanisms located at the distal end of the catheter. The steering lever mechanism is marked with a "0" on the handle to indicate when the Posterior Pad is orientated in line (straight) with the catheter. When fully rotated in either direction, the Posterior Pad is orientated approximately 90° to the catheter. The following picture, Figure 3-9, illustrates the degree of rotation possible for the Posterior Pad when attached to the Posterior Pad Catheter.

Figure 3-9: Distal Portion of the Posterior Pad Catheter

A polyethylene cable is pinned, with a stainless steel pin, to the steering lever mechanism inside the catheter handle. The cable runs through the inner shaft of the catheter, loops through the distal wheel component of the pad attachment mechanism in the catheter tip, runs back through the inner shaft of the catheter, and is again pinned to the steering lever mechanism in the catheter handle. Figure 3-10 illustrates the rotational features of the distal pad attachment mechanisms on the Posterior Pad Catheter.

Figure 3 ■ 10: Distal Posterior Pad Catheter Components

The cable is locked in place at the distal tip via cable locking stainless steel pins and cyanoacrylate adhesive. The distal wheel component of the pad attachment mechanism is made of PEEK and is keyed to the axle of the pad attachment mechanism. The axle is made of PEEK and is press-fit into the cap of the pad attachment mechanism. The axle is also keyed to the post on the Posterior Pad. The post on the Posterior Pad is made of PEEK and is held in place by a PEEK post screw. Movement of the steering lever mechanism on the catheter handle, in turn rotates the distal wheel, which rotates the axle. The axle rotates the post, which ultimately rotates the Posterior Pad.

The Posterior Pad is released from the catheter by disabling a tamper proof seal (0.25 inch wide perforated polypropylene tape) and opening the lever arm of the handle (reference Figure 3-11).

Figure 3-11: Posterior Pad Catheter Handle

Lever Arm

Steering Lever

Tamper Proof Seal Location

The lever arm is anchored with four set screws to the stainless steel pull-wire. The stainless steel pull-wire runs the length of the catheter and has a solid stainless steel ball at the distal tip. The ball is mechanically attached to the locking clip of the distal pad attachment mechanism. The locking clip is made of PEEK material and is mechanically interfaced with the post of the Posterior Pad. Figures 3-12 and 3-13 illustrate the components and location of the pad attachment mechanisms when the Posterior Pad is attached and released from the Posterior Pad Catheter, respectively.

Figure 3-12: Posterior Pad Catheter with Pad Figure 3-13: Posterior Pad Catheter with Attached Pad Released (Locking Clip Retracted)

Opening the lever arm of the catheter handle retracts the pull-wire, which in turn retracts the locking clip. Retraction of the locking clip allows the post of the Posterior Pad to detach from the wheel in the distal pad attachment mechanism of the catheter, thereby releasing the Posterior Pad from the Posterior Pad Catheter.

3.2.1.2 Subvalvular Chord Assembly

The load-bearing Subvalvular Chord of the iCoapsys device is made of the same materials and dimensions as the chord utilized in the Coapsys device (ultra high molecular weight polyethylene braid with an expanded polytetrafluorethylene [ePTFE] outer sheath).

In order to facilitate the percutaneous delivery of the implant, the distal end of the chord is connected to a leader wire that is approximately 63 inches long. The leader wire is 0.014 inches in diameter with a platinum distal tip and is designed to act like a standard gυidewire. A 0.25 inch stainless steel strain relief is swaged over the leader and chord connection to provide a means of attaching the leader to the chord. The leader also contains a stainless steel band that is swaged in place approximately two inches from the strain relief to provide a "stop" that facilitates attachment of the Subvalvular Chord to the Sizing Instrument utilized during the procedure.

The iCoapsys Subvalvular Chord is provided with a removable PEBAX chord cover. The chord cover is tungsten loaded to facilitate fluoroscopic visualization during the procedure and has a hydrophilic coating designed to ease insertion of the chord assembly through the delivery/procedural devices and through the myocardium. The chord cover is designed to be able to be placed back on the chord once removed, if the device needs to be exchanged for a different size.

The proximal end of the Subvalvular Chord contains an "insert." The insert of the iCoapsys Subvalvular Chord is identical to the insert on the Coapsys Subvalvular Chord and functions to connect the Subvalvular Chord to the Posterior Pad (reference Figure 3-14).

The insert contains a nickel-cobalt-chromium-molybdenum alloy (MP35N) pin locking mechanism within the same PEEK material as used for the Posterior and Anterior Pads. The insert is designed to fit into the open key hole located between the basal and apical heads of the Posterior Pad, identical to the Coapsys (reference Figures 3-1, 3-3, and 3-4).

A large silicone o-ring is sutured to the proximal side of the insert. The o-ring is designed to prevent the Subvalvυlar Chord from being advanced beyond the area that is readily accessible during the procedure and is easily removed from the insert by cutting the suture thread.

3.2.1.3 Anterior Pad

The Anterior Pad is made of the same PEEK material as the Posterior Pad and has the same polyester covering over the elements that contact the epicardial surface of the heart. The polyester covering is secured to the PEEK material via a polyester suture. A platinum/iridium coil is threaded over a portion of the suture material to ensure that the pad location is visible under fluoroscopy. The Anterior Pad is available in two sizes (2.5cm and 3.0cm), similar to the Coapsys. The size of the pad is determined by the epicardial surface area of the pad and correlates to the equivalent surface area of epicardial view of the corresponding Posterior Pad. In order to facilitate percutaneous delivery of the Anterior Pad, the body of the Pad consists of four major components that, when expanded, result in an epicardial surface area and geometry that is identical to the Coapsys Anterior Pad. The four components along with the Anterior Pad attachment mechanisms are explained in further detail in subsequent sections of this document. Figures 3-15 through 3-18 depict the iCoapsys Anterior Pad. Note: The Coapsys Anterior Pad is also illustrated for reference purposes.

Figure 3-15: Anterior Pad Family (Epicardial View)

Figure 3-16: Anterior Pad Family (Pericardial View)

The body of the Anterior Pad is comprised of four major components; the core, yoke and two wings. During percutaneous delivery of the Anterior Pad, the four components are collapsed. Once delivered into the pericardial space, the Anterior Pad is expanded and locked. Figures 3-19 and 3-20 depict the components of the Anterior Pad in the collapsed and expanded configurations, respectively.

MP35N hinge pins are utilized to maintain the orientation of the components when the pad is collapsed and expanded. The outer sides of the wing components contain wing indicator pins that also facilitate fluoroscopic visualization of the position of the wings when in the collapsed and expanded configuration. The yoke and core components each contain an MP35N alignment pin, which when aligned and visualized under fluoroscopic evaluation, indicates the pad is fully expanded. The following picture, Figure 3-21, illustrates the pin configurations under fluoroscopic visualization when the Anterior Pad is collapsed and expanded (prior to the staple deployment).

Figure 3-21: Fluoroscopic Pin Images

The core component of the iCoapsys Anterior Pad contains the staple mechanisms similar to the Coapsys Anterior Pad. The staple mechanisms contained in the core component consist of a MP35N forward stop pin (designed to prevent premature staple deployment), an MP35N staple, and an MP35N over-snap pin (designed to lock the staple in place once deployed). The following Figure 3-22 illustrates the staple mechanisms that are visualized via fluoroscopic visualization.

The Anterior Pad is attached to the distal end of the Anterior Pad Catheter, which is utilized to guide the pad into position and expand it to its final configuration (reference Figure 3-23).

Figure 3-23: Anterior Pad Catheter

The Anterior Pad Catheter shaft contains three lumens. The following illustration, Figure 3-24, depicts a cross-section of the tri-lumen catheter shaft. Figure 3-24: Tn-Lumen Catheter Shaft

The middle lumen is made of a PEBAX tube reinforced with a stainless steel braid. The distal segment of the tube is made of 25D PEBAX and is approximately one inch long. The ID of the distal segment is approximately 0.125 inches and the OD is approximately 0.220 inches. The proximal segment of the tube is made of an outer layer of 70D PEBAX and the inner layer is 63D PEBAX. The proximal segment is approximately 20 inches long and has the same ID and OD as the distal end.

A steering collar, made of PEEK material, is clamped with stainless steel screws to the distal end of the middle lumen of the catheter shaft via a stainless steel lumen connector. (Reference Figure 3-25.)

Figure 3-25: Anterior Pad Catheter Steering Collar

The lumen connector is stabilized with blue 25D PEBAX re- flowed over the connector and catheter shaft. The steering collar contains a through lumen for the pad release core shaft, which contains the wing control core shaft, which contains the staple deployment core shaft (pull-wire); all of which traverse the middle lumen of the catheter shaft.

The outer two lumens of the Anterior Pad Catheter shaft are made of PEEK material and are approximately 20 inches in length. The IDs of the outer lumens are approximately 0.039 inches and the ODs are approximately 0.052 inches. The distal ends of the outer two lumens extend to the 25D segment of the middle lumen and are secured with a PEEK end-cap press-fit over the three lumens. The proximal three lumens are clamped into the urethane handle of the Anterior Pad Catheter. An FEP heat shrink wrap is located over the tri-lumen shaft of the catheter.

The handle of the Anterior Pad Catheter is labeled "Anterior" and contains the control mechanisms to expand and position the Anterior Pad. The handle of the Anterior Pad Catheter also contains control mechanisms to deploy a staple (attaching the Anterior Pad to the Subvalvular Chord) and release the Anterior Pad from the Anterior Pad Catheter (reference Figure 3-26).

Figure 3-26: Anterior Pad Catheter Handle

The Anterior Pad is expanded by advancing the wing control mechanism forward (distally) on the handle. The wing control mechanism is clamped and secured with set screws to an inner stainless steel wing control core shaft. The wing control core shaft extends from the handle, through the middle lumen of the catheter and is threaded into the yoke component of the Anterior Pad. Advancing the wing control mechanism toward the distal portion of the catheter advances the wing control core shaft distally, which in turn moves the yoke distally and deploys the wings of the Anterior Pad. A mechanical fit between the yoke and wings maintains the expanded position. The wing control core shaft is released from the yoke by rotating the wing control mechanism on the catheter handle counter-clockwise. Rotation of the wing control mechanism un-threads the wing control core shaft from the yoke component of the Anterior Pad.

The steering lever mechanism on the Anterior Pad Catheter handle is used to orient the Anterior Pad in the correct location, similar to the Posterior Pad. However, the Anterior Pad rotates approximately 90° in one direction, as only this counter clockwise rotation is required for vascular clearance and final positioning of the device. The following picture, Figure 3-27, illustrates the degree of rotation possible for the Anterior Pad when attached to the Anterior Pad Catheter.

Figure 3-27: Distal Portion of the Anterior Pad Catheter

The steering lever mechanism is marked with a "0" on the handle to indicate when the Anterior Pad is orientated in line (straight) with the catheter.

Similar to the Posterior Pad Catheter, a polyethylene cable is pinned to the steering lever mechanism of the Anterior Pad Catheter inside the catheter handle. The cable runs through one of the PEEK catheter shaft lumens, threads through the steering collar of the pad attachment mechanism, and returns to the steering lever mechanism in the catheter handle through the other PEEK catheter shaft lumen (reference Figure 3-28). igure 3-28: Distal Portion of the Anterior Pad Catheter

The cable is locked in place at the distal tip of the catheter by a knot in the cable, preventing the cable from sliding through the holes in the steering collar. Movement of the steering lever mechanism of the catheter handle rotates the steering collar of the catheter, which is directly connected to the pad via the pad release core shaft.

Rotation of the staple deployment mechanism on the handle of the Anterior Pad Catheter deploys the staple through the Subvalvular Chord. The inner portion of the staple deployment mechanism on the catheter handle utilizes a worm gear/screw mechanism, such that when the staple deployment mechanism is rotated counterclockwise, the inner worm gear retracts the worm screw without rotating the screw. The worm gear/screw is made of acetal and PEEK material. The screw is anchored with set screws to the stainless steel staple deployment pull-wire that extends the length of the catheter through the wing control core shaft in the middle lumen of the catheter. The distal end of the staple deployment pull-wire has a ball configuration that is constrained in a stainless steel pull-cylinder. The pull-cylinder is located inside the core component of the Anterior Pad, distal to the staple.

Counter-clockwise rotation of the staple deployment mechanism on the catheter handle disables two strips of tamper proof seals (of the same material as the Posterior Pad Catheter) and retracts the staple deployment pull-wire, which in turn pulls the cylinder proximally toward the staple. The cylinder advances the staple past the forward stop pin, through the Subvalvular Chord, and past the over-snap pin inside the core component of the Anterior Pad. The following picture, Figure 3-29, illustrates the fluoroscopic images of the staple configuration pre and post staple deployment.

Figure 3-29: Fluoroscopic Staple Deployment Images

Once the staple is deployed, the pull-cylinder is allowed to move past the staple via the internal mechanical design of the core component of the Anterior Pad and is no longer attached to the staple mechanism. (Note: The staple deployment mechanism of the iCoapsys Anterior Pad is identical to the Coapsys Anterior Pad, with the exception of the orientation of the over-snap pin on the Anterior Pad.)

The pad release mechanism of the catheter handle is used to disengage the Anterior Pad from the Anterior Pad Catheter. The pad release mechanism of the handle is clamped to a stainless steel pad release core shaft. The pad release core shaft extends the length of the catheter through the middle lumen and is threaded into the yoke component of the Anterior Pad. Counter-clockwise rotation of the pad release mechanism un-threads the pad release core shaft from the yoke component of the Anterior Pad.

3.2.3 iCoapsys Delivery System

In addition to the above described implant, the iCoapsys System includes several ancillary delivery system devices. Since the iCoapsys implant is designed for implantation via a percutaneous subxiphoid approach, several modifications to the Coapsys delivery system devices were necessary. As well, several additional devices were designed to facilitate the percutaneous procedure of the iCoapsys implant.

The iCoapsys implantation procedure comprises four distinct phases: (i) Percutaneous Pericardial Access, (ii) Site Identification, (iii) Device Implantation, and (iv) Sizing & Therapeutic Evaluation, Each phase involves the use of several devices. A detailed description of each device, utilized within each phase of the procedure, is provided in the following sections. (Note: Where possible, a comparison to the surgical Coapsys delivery system devices is also provided.)

3.2.3.1 Percutaneous Pericardial Access

The Percutaneous Pericardial Access phase utilizes the 8F Introducer, Pericardial Access Needle, 0.018" Pericardial Guidewire, Access Sheath (which includes a sheath, dilator, and securement clamp), and Catheter Securement Clip (reference Figure 3-30).

Figure 3-30: Percutaneous Pericardial Access Phase Delivery Devices

3.2.3.1.1 8F Introducer

The 8F Introducer is a two part assembly designed to bluntly navigate through tissue from the incision point to the intended pericardial access location. The 8F Introducer consists of a sheath with a removable blunt- tipped polymeric obturator (reference Figure 3-31).

The sheath is constructed of a stainless steel hypotube, approximately 6.5 inches in length, with laser etched markings every centimeter to aid in external visualization of depth penetration. The ID of the hypotube is 0.11 inches and the OD is 0.13 inches. The proximal end of the hypotube is bonded with epoxy to a female luer.

The blunt-tipped obturator is a white PEBAX tube, slightly longer than the stainless steel hypotube. The OD of the rube is 0.1 inches. The proximal end of the removable obturator is bonded with epoxy to a double- ended cap. The double-ended cap interfaces with the female luer on the stainless steel hypotube (sheath).

3.2.3.1.2 Pericardial Access Needle

The Pericardial Access Needle is a rigid, sharp pointed tube designed to penetrate the pericardial sac and provide access for the 0.018" Pericardial Guidewire into the intrapericardial space without penetrating the epicardial surface of the heart (reference Figure 3-32).

Figure 3-32: Pericardial Access Needle

The Pericardial Access Needle consists of a rigid stainless steel tube, approximately eight inches in length, with a sharp tip at the distal end, a laser etched mark approximately 6.5 inches from the distal tip (indicating when the distal tip of the needle will exit the 8F Introducer), and with tubing connected to a y- adapter and Touhy at the proximal end.

The Pericardial Access Needle will be available in three models; one with a gap length of 0.020 inches, one with a 0.040 inch gap length, and one with a 0.060 inch gap length designed to accommodate various thicknesses of the pericardial membrane. The following picture, Figure 3-33, illustrates the distal tip of the needle, including the gap location.

Figure 3-33: Pericardial Access Needle (Distal Tip)

The ED of the stainless steel tube is approximately 0.02 inches at the distal tip and transitions to an ID of approximately 0.05 inches within approximately 0.30 inches of the tip. The sharp, pointed tip (approximately 0.080 inches in length) is followed by an abrupt decrease in the outer diameter (for either 0.040 or 0.060 inches) which is then followed by an abrupt increase in diameter that serves as a "stop." Note: The "stop" functions to limit the maximum penetration depth of the needle to approximately 0.080 inches and the reduced diameter gap between the sharp tip and the "stop" is designed to "capture" the pericardium. The capture mechanism is designed to allow traction to be applied to the needle, pulling the pericardium away from the epicardial surface.

The proximal end of the needle is bonded with epoxy to a male luer. The male luer is attached to a female luer, which is bonded with epoxy to clear polyvinyl chloride (PVC) tubing approximately 12 inches in length. The proximal end of the tubing is bonded with epoxy to a y- adapter and Touhy. Note: The proximal tube and y- adapter are designed to facilitate contrast injections and wire entry. 3.2.3.1.3 0.018" Pericardial Guidewire

The 0.018" Pericardial Guidewire is a stainless steel wire with an ultra soft, flexible, short tip. The 0.018" Pericardial Guidewire is similar design to other commercially available 0.018" Percutaneous Guidewires and is designed to pass through the Pericardial Access Needle after the Pericardial Access Needle is secured through the pericardium.

The wire is approximately 43 inches in length with a tapered distal tip. The distal 0.5 inches of the core wire is a flat ribbon 0.003 inches in width and 0.001 inches in height. The tapered section of the wire contains an 8% tungsten/92% platinum coil wire 0.003 inches in diameter. The coil extends 3.5 inches from the distal tip of the guidewire. The coil is brazed to the core wire at the proximal location and is welded to the flat ribbon core wire at the distal end.

Note: Standard commercially available devices are utilized to further dilate the pericardial access location.

3.2.3.1.4 Access Sheath

The Access Sheath is a flexible polymer tube assembly that is designed to create and maintain an access conduit for delivery of the iCoapsys implant The Access Sheath consists of three components; a sheath, dilator, and securement clamp (reference Figure 3-34).

The sheath is a 53F rube approximately eight inches in length and is comprised of three segments; a distal tip, a flexible mid-segment, and a rigid proximal segment (reference Figure 3-35).

The distal tip of the sheath is made of 20% barium loaded acrylontrile butadiene styrene (ABS) material. The ID is approximately 0.70 inches and the maximum OD is 0.85 inches. The tip segment has an angled edge [making the tip long on one side (1.19 inches) and short on the other (0.40 inches)]. The short side of the tip has an extension outward from the tip that creates a lip approximately 0.10 inches in length.

The distal tip is followed by a flexible mid-segment that is approximately four inches in length. The flexible segment is silicone material reinforced with a continuous stainless steel coil. The ID of the flexible mid-segment is 0.70 inches and the OD is 0.79 inches.

The flexible mid-segment is bonded with cyanoacrylate adhesive on the proximal end to a rigid segment that is approximately 3.6 inches in length. The rigid segment is made of polycarbonate. The ID of the proximal rigid segment is 0.70 inches and the OD at the distal end is 0.85 inches. The OD of the rigid segment has markings to indicate whether the distal tip is in a locked (padlock symbol is closed) or unlocked position (padlock symbol is open). A locked symbol correlates with the longer end of the distal tip. The unlocked symbol correlates with the shorter edge (and lip) of the distal tip. When in use, if the locked symbol is anterior, it signifies that the lip of the sheath is engaged with the pericardium. If the unlocked symbol is in the anterior position, it signifies the lip of the sheath is not engaged with the pericardium.

Both the inner and outer surfaces of the entire sheath have a lubricious parylene coating.

The dilator is approximately 12 inches long and is comprised of three segments; distal tip, body, and proximal handle (reference Figure 3-36). The dilator also contains an inner through lumen 0.042 inches in diameter to accommodate the 0.035" Guidewire used during the procedure.

The OD of the end of the distal tip is less than 0.118 inches and is molded from 15-18% barium loaded silicone material. The OD of the distal tip transitions to 0.69 inches over approximately 3.7 inches. The body of the dilator is approximately 7.6 inches long and has an OD of 0.67 inches. The body of the dilator is made of silicone material. The proximal end of the dilator is bonded with room temperature vulcanizing (RTV) sealant to a silicone pad creating a "dilator handle" approximately 1.25 inches wide, 1.75 inches long, and 0.5 inches thick.

The entire outer surface of the dilator has a lubricious parylene coating. (Note: When packaged, the dilator contains a removable nitinol mandrel placed in the inner lumen to prevent damage to the distal tip of the dilator.)

The securement clamp is a two part acetal hinged component with a screw tightening closure mechanism (reference Figure 3-37).

When tightened, the ID of the clamp portion is 0.840 inches. When closed, the proximal configuration is

- I l l - formed to enclose the proximal segments of the sheath and the dilator handle, holding them together for insertion. The Securement Clamp is also used to secure the access sheath in location by placing the clamp on the rigid portion of the sheath at a location that maintains retraction of the sheath to the patient^ chest.

3.2.3.1.5 Catheter Securement Clip The Catheter Securement Clip is a hinged clamp, connected to two proximal clips, that is designed to slide over the proximal end of the Access Sheath (external to the patient) and stabilize the iCoapsys catheters and components during the procedure (reference Figures 3-38 and 3-39).

Figure 3-38: Catheter Securement Clip

Figure 3-39: Catheter Securement Clip with Access Sheath

The hinged clamp is made of two acetal components that are held together with a screw tightened closure mechanism. When tightened, the inner diameter of the clamp is approximately 0.84 inches. The clamp portion of the device contains two malleable posts labeled "ANT' (indicating Anterior) and "POST' (indicating Posterior) designed to hold the various anterior and posterior devices, respectively, that are utilized during the procedure. Each post consists of an aluminum wire (approximately four inches in length) with a white polyolefin coating. The distal ends of the posts are pinned to the hinged clamp. The proximal end of each post is pinned to a separate polycarbonate spring-loaded pinch clip.

3.2.3.2 Site Identification

The Site Identification phase utilizes the Anterior and Posterior Vacuum Lines, Vacuum Tubing Set, Intra Cardiac Echo (ICE) Delivery Catheter, Posterior Sighting Catheter, and Anterior Sighting Catheter (reference Figure 3-40). Note: The Vacuum Tubing Set is not included in the following picture.

Figure 3-40: Site Identification Phase Delivery System Devices

3.2.3.2.1 Vacuum Tubing Set

The Vacuum Tubing Set consists of two individual clear PVC tubing sets, identical to those utilized for the surgical Coapsys Device (reference G020279). Like the surgical Coapsys Device, the Vacuum Tubing Set is designed to supply vacuum from the vacuum source to the delivery system devices during the procedure.

One tubing set bifurcates into a ⁴⁴Y," while the other is a straight tube with suction filter. The bifurcated tube is approximately 150 inches in length, with an ID of 0.24 inches and an OD of approximately 0.38 inches (reference Figure 3-41).

Figure 3-41: Bifurcated Tube

A clear PVC connector is located in the middle of the device. A suction connector is located at the proximal end of the bifurcated tube and each of the distal ends terminate with a high flow 3-way stopcock.

The straight tube is approximately 75 inches in length with suction connectors at both ends. The mid segment of the tube is connected in-line with a standard suction filter.

3.2.3.2.2 Anterior and Posterior Vacuum Lines

The Anterior and Posterior Vacuum Lines are green (Anterior) and orange (Posterior) tubes with luer fittings attached at all ends. The Anterior and Posterior Vacuum Lines are designed to facilitate the supply of vacuum from the Vacuum Tubing Set to the delivery devices during the procedure.

The tubes are constructed from PEBAX material and are approximately 36 inches in length. The IDs of the tubes are 0.13 inches and the ODs are 0.18 inches. A continuous stainless steel wire spring coil is located in the inner lumen of each tube. The stainless steel wire is 0.016 inches in diameter and is coiled into a 0.125 inch diameter tube. Female luers are friction fit into one end of each tube and male luers are fit into the other end of each tube. A polyolefin heat shrink wrap approximately one inch long is located on the OD of the tubes. The heat shrink is labeled "ANT" on the anterior tube and "POST' on the posterior tube. 3.2.3.2.3 ICE Delivery Catheter

The ICE Delivery Catheter is a single lumen catheter, approximately 25 inches long, that is designed to facilitate the placement and control of the echocardiography imaging catheters required for visualization during the procedure (reference Figure 3- 42).

The ICE Delivery Catheter consists of a proximal strain relief, Touhy, vacuum manifold, catheter shaft with a distal shapeable segment, and a distal vacuum stabilization cup.

The proximal strain relief is a single lumen PVC tube approximately four inches long. The ID of the strain relief is 0.24 inches and the OD is 0.38 inches. The strain relief is bonded with ultraviolet adhesive (acrylate urethane blend) to a 0.25 inch long stainless steel hypotube with an ID of 0.22 inches and an OD of 0.25 inches. The hypotube is bonded with epoxy to a luer that is threaded into the proximal end of the Touhy. (Note: The Touhy is utilized to secure the ICE imaging catheter to the ICE Delivery Catheter.) The Touhy is snap-fit to a polycarbonate vacuum manifold that is approximately five inches long. The vacuum manifold contains an inner through lumen and a side vacuum port. The distal side of the vacuum manifold is bonded with epoxy to another one inch long stainless steel hypotube, similar to the hypotube utilized previously. The proximal end of the catheter shaft is fed into the distal end of the hypotube and bonded with epoxy adhesive. A polyolefϊn heat shrink, approximately one inch in length, is located over the bond and is labeled "ANT."

The catheter shaft is approximately 20 inches in length and consists of a proximal and distal segment. The proximal segment is approximately 17 inches long and consists of a 20% Barium loaded, 62D, blue PEBAX single lumen rube reinforced with a stainless steel braid. The ID of the tube is 0.195 inches and the OD is 0.213 inches. White numerical markings are located on the outer surface of the tube, approximately 8 inches from the distal tip. The numerical markings are spaced one centimeter apart and extend for 10 cm proximally on the outer shaft material that are used as a reference for the distance inserted through the Access Sheath.

The distal segment of the catheter shaft is approximately three inches long and consists of a stainless steel hypotube inside the same shaft material as the proximal segment of the catheter. The outer portion of the distal catheter shaft segment consists of a 20-25% Barium loaded, 25 D, blue PEBAX covering. The ID of the stainless steel hypotube is 0.164 inches and the OD is 0.188 inches. The hypotube is slotted and malleable for approximately two inches near the distal end.

The distal end of the catheter shaft is pinned to a polycarbonate vacuum stabilization cup (reference Figure 3-43).

igure 3-43: ICE Delivery Catheter Distal Vacuum Stabilization Cup

The vacuum stabilization cup is approximately 0.85 inches long, 0.40 inches wide, and 0.18 inches tall. The inner portion of the cup contains a through lumen to the stainless steel hypotυbe. Two platinum/iridium (90%/5%) coils are bonded with ultraviolet adhesive to the pericardial surface of the vacuum stabilization cup to aid in fluoroscopic visualization. (Note: When utilized during the procedure, the imaging array of the imaging catheter is housed in the vacuum stabilization cup.)

3.2.3.2.4 Posterior Sighting Catheter

The Posterior Sighting Catheter is a dual-lumen catheter designed to facilitate the identification of the proper epicardial location for the Posterior Pad and introduction of the Posterior Needle (reference Figure

3-44).

Figure 3-44: Posterior Sighting Catheter

The catheter is approximately 28 inches in length and has a vacuum manifold, vacuum lumen, needle lumen, needle lumen steering mechanism, and a distal polycarbonate cup.

The proximal polycarbonate vacuum manifold contains two through lumens; a vacuum lumen (that exits to the side of the manifold) and a needle lumen (that exits to the proximal end of the manifold). A luer hub is bonded with ultraviolet adhesive and threaded into the side of the manifold at the vacuum lumen opening, creating a vacuum port. The vacuum lumen catheter shaft is bonded with ultraviolet adhesive to the vacuum lumen through-hole on the distal side of the manifold. A Touhy is bonded with ultraviolet adhesive and threaded into the proximal end of the manifold at the needle lumen through-hole location. The needle lumen on the distal end of the manifold is bonded, with ultraviolet adhesive, to a stainless steel hypotube approximately 7.5 inches long. The ID of the hypotube is 0.135 inches and the OD of the hypotube is 0.148 inches. A polyolefϊn heat shrink labeled "POST' is placed around the outer portion of the manifold.

The vacuum lumen catheter shaft is approximately 21 inches long and is constructed of PEBAX material ranging in durometer (proximal to distal) from 7OD to 4OD and is reinforced with a stainless steel braid (reference Figure 3-45).

Figure 3-45: Catheter Shaft Cross Section

Stiffening Wires

The vacuum lumen also contains two stainless steel stiffening wires, 0.013 inches in diameter, embedded in the PEBAX material. The ID of the vacuum lumen is 0.09 inches and the OD is 0.22 inches at the proximal end and 0.19 inches at the distal end. The outside of the vacuum lumen has black ink markings every one centimeter for approximately 15 cm near the proximal end. The proximal markings correlate with the length of the Access Sheath and are used as a reference during insertion of the Posterior Sighting Catheter. The distal end of the vacuum lumen shaft extends over a stainless steel adapter that is press-fit into the distal orifice.

The needle lumen catheter shaft is approximately 14 inches long and is constructed of 4OD PEBAX reinforced with a stainless steel flat ribbon coil. An ePTFE liner is located on the inner portion of the needle lumen shaft. The ID of the needle lumen shaft is 0.10 inches and the OD of the needle lumen is 0.12 inches. The proximal end of the needle lumen shaft is bonded with cyanoacrylate adhesive to the stainless steel hypotube at the manifold. The distal end of the lumen is maintained in close proximity to the vacuum lumen via 25D PEBAX material.

A needle lumen steering mechanism traverses the entire length of the needle lumen catheter shaft and has three segments; proximal, mid, and distal (reference Figure 3-46).

Figure 3-46: Needle Lumen Steering Mechanism

Prox fima >l

The proximal segment is approximately nine inches long and is constructed of a stainless steel hypotube. The DD of the hypotube is 0.077 inches and the OD is 0.095 inches. The proximal end of the hypotube is bonded with ultraviolet adhesive to a female luer. The hypotube passes through the Touhy and the vacuum manifold and traverses into the proximal portion of the needle lumen shaft of the catheter. The inner portion of the hypotube contains a drive cable that extends from the proximal end of the hypotube through the entire mid segment of the needle lumen steering mechanism. The hypotube is bonded with epoxy to the drive cable, near the proximal end of the hypotube.

The mid segment of the needle lumen steering mechanism is approximately 15 inches long and consists of a drive cable that is constructed of a triple layer, flat coiled stainless steel ribbon wire with a 55D PEBAX outer layer. The ID of the mid segment is 0.047 inches and the OD is 0.073 inches. The distal end of the stainless steel ribbon wire is welded to the distal portion of the needle lumen steering mechanism.

The distal portion of the needle lumen steering mechanism is a curved stainless steel hypotube (0.670 inches in length) that has a stainless steel ball welded around the outer distal portion of the tube (creating what is referred to as an inner solid marker during the alignment phase of the procedure). The ID of the tube is 0.053 inches, while the OD of the tube is 0.065 inches. Figures 3-47 and 3-48 illustrate the distal portion of the Posterior Sighting Catheter. Figure 3-47: Distal Catheter (Pericardial View)

The distal polycarbonate cup is approximately 0.5 inches in diameter and consists of three polycarbonate half spheres (inner, mid, and outer) and a stainless steel sighting ring (referred to as an "outer ring"). Figures 3- 49 and 3-50 illustrate the distal cup assembly of the Posterior Sighting Catheters.

The inner sphere is bonded with ultraviolet adhesive to the distal portion of the needle lumen steering mechanism (just proximal to the stainless steel ball). The mid sphere (also referred to as the vacuum cup) is fit over the inner sphere on the needle lumen steering mechanism and is bonded with ultraviolet adhesive to the stainless steel adapter at the distal end of the vacuum shaft. (Note: A polycarbonate tip is bonded with ultraviolet adhesive over the adapter on the inside of the mid sphere.) The outer sphere is bonded with ultraviolet adhesive to the needle lumen steering mechanism, proximal to the mid sphere. The inner and outer spheres are connected to the needle lumen control feature and sandwich the mid sphere, which is connected to the vacuum lumen. The mid sphere is stabilized in position during the procedure via the vacuum catheter shaft, while the inner and outer sphere facilitate movement of the needle lumen in order to position the sighting ring around the inner solid marker. The sighting ring is 0.025 inches thick and has a diameter of 0.25 inches. The sighting ring is bonded with ultraviolet adhesive to the outer surface of the outer sphere.

The distal cup of the catheter is secured to the epicardial surface by applying vacuum to the vacuum port of the proximal vacuum manifold. Advancing and retracting, along with twisting the proximal needle lumen steering mechanism in either direction, rotates the distal cup such that the ball can be centered in the ring under fluoroscopic visualization. Alignment of the ball and ring features aid in providing the proper needle trajectory from the needle lumen of the catheter through the myocardium. Tightening the Touhy locks the needle lumen steering mechanism in position.

3.2.3.2.5 Anterior Sighting Catheter

The Anterior Sighting Catheter is similar in design to the Posterior Sighting Catheter and is designed to facilitate the identification of the proper epicardial location for the Anterior Pad and introduction of the Anterior Needle and Snare (reference Figure 3-51).

Figure 3-51: Anterior Sighting Catheter

The Anterior Sighting Catheter is approximately 23 inches in length and has similar components as the Posterior Sighting Catheter. The proximal portions of the catheters are mirror images of each other with the only difference being that the vacuum manifold is labeled "ANT" for the Anterior Sighting Catheter instead of "POST." The vacuum lumen of the Anterior Sighting Catheter is shorter than the Posterior Sighting Catheter and contains a shapeable segment at the distal end.

The vacuum lumen of the Anterior Sighting Catheter is approximately 15 inches long and is constructed of similar materials as the Posterior Sighting Catheter. The proximal portion is constructed of the same PEBAX shaft material as the Posterior Sighting Catheter, ranging in durometers (proximal to distal) from 7OD to 4OD and is reinforced with a stainless steel braid. The vacuum lumen also contains two of the same stainless steel stiffening wires, 0.013 inches in diameter, embedded in the PEBAX material. The ID and OD of the Anterior Sighting Catheter vacuum lumen is the same as the Posterior Sighting Catheter. The outside of the vacuum lumen has black markings every one centimeter for approximately 10 cm near the proximal end. Like the Posterior Sighting Catheter, the proximal markings correlate with the length of the Access Sheath and are used as a reference during insertion of the Anterior Sighting Catheter. Note: The markings on the Anterior Sighting Catheter are the same distance from the center distal needle lumen as the markings on the ICE Delivery Catheter are from the distal stabilization vacuum cup.

Unlike the Posterior Sighting Catheter, the distal portion of the Anterior Sighting Catheter vacuum lumen has a stainless steel hypotube, approximately two inches in length, which is inserted into the 4OD PEBAX proximal shaft material. Figures 3-52 and 3-53 illustrate the distal portion of the Anterior Sighting Catheter. Figure 3-53: Distal Cup (Epicardial View)

The hypotube is slotted and malleable, for approximately one inch at the distal end, and has a 25D PEBAX outer layer that extends over the hypotube. The malleable segment facilitates proper positioning of the catheter during the procedure. The hypotube is welded to a stainless steel adapter at the distal end of the vacuum lumen.

The needle lumen of the Anterior Sighting Catheter is shorter, larger in diameter, and configured of slightly different materials than the Posterior Sighting Catheter. The Anterior Sighting Catheter needle lumen shaft is approximately 14 inches in length and has a proximal hypotube and distal shaft. The proximal hypotube is approximately five inches long and has the same ID and OD as the Posterior Sighting Catheter. The proximal end of the hypotube is bonded with ultraviolet adhesive to the vacuum manifold (identical to the Posterior Sighting Catheter). The distal end of the hypotube is bonded with cyanoacrylate adhesive to the distal shaft. The distal shaft of the needle lumen is approximately nine inches long and has an ID of 0.124 inches and an OD of 0.134 inches. The needle lumen is constructed of a 55D PEBAX material without any stainless steel braid reinforcement, as opposed to the 4OD PEBAX reinforced with a stainless steel braid of the Posterior Sighting Catheter.

The needle lumen of the Anterior Sighting Catheter is maintained in close proximity to the vacuum lumen in an identical manner as the Posterior Sighting Catheter.

The needle lumen steering mechanism of the Anterior Sighting Catheter utilizes the same materials for the proximal, mid, and distal segments as the Posterior Sighting Catheter. However, the dimensions within each segment are modified.

The proximal segment (stainless steel hypotube) is approximately eight inches long and has an E) of 0.100 inches and an OD of 0.120 inches. The proximal end of the hypotυbe is bonded with ultraviolet adhesive to a hub and the inner lumen of the hypotube contains a drive cable that extends from the proximal end of the hypotυbe through the entire mid segment of the needle lumen steering mechanism. The hypotube is bonded with epoxy to the drive cable, near the proximal end of the hypotube.

The mid segment of the needle lumen steering mechanism is approximately 12 inches long and consists of a drive cable that is constructed of a triple layer, flat coiled stainless steel ribbon wire with a 55D PEBAX outer layer. The ID of the mid segment is 0.070 inches and the OD is 0.100 inches. The distal end of the stainless steel ribbon wire is welded to the distal portion of the needle lumen steering mechanism.

The distal portion of the needle lumen steering mechanism is similar to the Posterior Sighting Catheter. The distal portion consists of a curved stainless steel hypotube (0.750 inches in length) that has a stainless steel ball (0.156 inches in diameter) welded around the outer distal portion of the tube (creating what is referred to as an inner solid marker during the sight identification phase of the procedure, reference Figure 3-53). The ED of the tube is 0.072 inches, while the OD of the tube is 0.083 inches.

The distal polycarbonate cup of the Anterior Sighting Catheter has the same outer diameter as the Posterior Sighting Catheter and is comprised of similar polycarbonate half spheres and the same sighting ring component. The only difference between the Anterior and Posterior Sighting Catheters is the larger size opening required to facilitate placement of the inner and outer half spheres over the needle lumen control mechanism of the Anterior Sighting Catheter.

3.2.33 Device Implantation

The Device Implantation phase utilizes the Posterior Needle, Anterior Needle, Snare, and Anterior Chord Protector (reference Figure 3-54).

3.2.3.3.1 Posterior Needle

The Posterior Needle consists of a needle tube and stylet and is designed to navigate through the needle lumen of the Posterior Sighting Catheter and subsequently through the myocardium of the left ventricle (reference Figure 3-55).

Figure 3-55: Posterior Needle (not to scale)

The posterior needle tube and stylet is approximately 70 inches in length, with the needle tube slightly shorter than the stylet.

The needle tube consists of a proximal hub, strain relief, shaft, and distal tip. The proximal hub is a female luer that is bonded with ultraviolet adhesive to the shaft A polyolefin strain relief, approximately 1.5 inches in length, is bonded with cyanoacrylate adhesive over the outer distal portion of the hub and outer proximal portion of the shaft.

The shaft is a single lumen, 72D PEBAX outer layer tube reinforced with a flat tungsten ribbon wire. The inner layer of the tube is a high density polyethylene (HDPE) material. The ID of the tube is 0.017 inches and the maximum OD is 0.042 inches. Figure 3-56 illustrates the distal segment of the needle tube with the stylet inserted through the needle tube lumen.

Figure 3-56: Schematic of the Posterior Needle Distal Tip

The distal tip is a single lumen, 50% tungsten loaded, 72D PEBAX material 0.400 inches in length. The proximal end extends onto the shaft of the needle tube. The ID of the distal tip is 0.015 inches and the maximum OD is 0.039 inches at the proximal end and tapers toward the distal end with a slight increase at the distal tip.

The outer surface of the needle tube has white marks every one centimeter for 10 cm, approximately 27 inches from the distal tip. Additionally, there are white marks every one centimeter extending four centimeters, approximately two inches from the proximal end of the tube. The distal marks are utilized as a reference for insertion depth during the procedure, while the proximal marks are utilized to identify the Posterior end of the needle tube once the tube creates a through lumen across the heart and exits on the anterior side.

The stylet is a solid nitinol wire with a sharp, pointed distal tip. The maximum OD of the wire is 0.014 inches and transitions to a sharp point at the distal tip. The proximal end of the stylet is bonded with ultraviolet adhesive to a male luer. The male luer of the stylet interfaces with the female luer of the needle tube.

A hydrophilic coating is located on the exterior portion of the needle tube beginning at the strain relief of the needle tube and continues over the distal end of the Posterior Needle Assembly (needle tube and stylet). 3.2.3.3.2 Anterior Needle

The Anterior Needle is similar to the Posterior Needle, consisting of a needle tube and stylet (reference Figure 3-57). The Anterior Needle is designed to navigate through the needle lumen of the Anterior Sighting Catheter and through the myocardial structures of the heart. The Anterior Needle also provides a path in which the Snare is delivered into the left ventricle of the heart. Therefore, unlike the Posterior Needle, the Anterior Needle has a larger diameter needle tube and is shorter in length.

Figure 3-57: Anterior Needle (not to scale)

The anterior needle tube and stylet is approximately 30 inches in length, with the needle tube slightly shorter than the stylet.

The needle tube consists of a proximal hub, strain relief, shaft, and distal tip and is constructed from the same materials as the Posterior Needle tube. However, the ID of the rube is 0.040 inches and the maximum OD is 0.053 inches, with a slight increase at the distal tip. Additionally, the outer surface of the Anterior Needle tube only has white marks every one centimeter for 10 cm, approximately 22 inches from the distal tip. The marks are utilized as a reference for insertion depth during the procedure.

Figure 3-58 illustrates the distal portion of the Anterior Needle tube with the stylet inserted through the needle tube lumen.

Figure 3-58: Distal Tip of Anterior Needle

Needle Tube

Layer

The Anterior Needle stylet is slightly modified from the Posterior Needle stylet in that a stainless steel coil wire (stylet coil) is located over the solid nitinol core wire and a PEBAX layer is located on the distal portion of the stylet assembly. The proximal ends of the nitinol core wire and stylet coil are bonded with ultraviolet adhesive to a male luer. The proximal end of the stylet coil is stepped to a smaller diameter around the core wire. The core wire is the same nitinol wire with a sharp, pointed distal tip as in the Posterior Needle stylet. The maximum OD of the nitinol wire is 0.017 inches. A stainless steel coil extends approximately 29 inches over the proximal end of the core wire towards the distal end. The OD of the stainless steel coil is 0.039 inches. Located approximately 0.20 inches from the distal tip of the core wire is a 50% tungsten loaded PEBAX layer. The PEBAX layer transitions from a maximum OD of 0.040 inches to the core wire at the distal tip.

Similar to the Posterior Needle Assembly, a hydrophilic coating is located on the distal half of the Anterior Needle Assembly. 3.2.3.3.3 Snare

The Snare device is a three-loop snare designed to capture the Posterior Needle once deployed in the left

The Snare consists of a distal three-loop design, PEBAX segment, and proximal core wire.

The distal three-loops are constructed of three 0.006 inch diameter solid nitinol wires wrapped with platinum/indium coils for enhance visibility. The loops are oπentated by a stainless steel collet (sieve). The collet is 0030 inches in thick and 0.030 inches in diameter with a center through-hole 0.0075 inches in diameter. Six through-holes, 0.0075 inches in diameter, are located, equally spaced, around the center through- hole. Each nitinol loop wire passes through two of the through-holes, creating the three-loop design, as detailed in the following illustration (reference Figure 3-60).

igure 3-60: Snare Loop Illustration

When fully expanded, the snare (distal view) is approximately 1.25 inches in diameter.

A nitinol core wire, 0.017 inches in diameter and 45 inches in length, is ground to a diameter at the distal end that permits the wire to traverse the middle through-hole of the collet. The distal portion of the core wire has a welded ball designed to maintain the collet on the core wire. The nitinol loop wires are coiled around the core wire on the proximal side of the collet and two PEBAX layers, 0.20 inches in length near the sieve and 1.3 inches in length covering the proximal end of the nitinol loop wires, are utilized to cover the transition of the loop wires to the core wire.

In order to facilitate insertion of the Snare into the needle tube of the Anterior Needle, a Snare introducer is pre-loaded onto the Snare. The Snare introducer is a stainless steel hypotube approximately six inches in length. The ID is 0.046 inches and the OD is 0.059 inches. A male luer is bonded with epoxy 0.365 inches from the proximal end of the hypotube.

Note: To facilitate movement of the Snare once deployed, a polycarbonate removable torque component is provided on the proximal portion of the core wire. The removable torque component is secured onto the core wire via a screw tightening mechanism. 3.2.3.3.4 Anterior Chord Protector

The Anterior Chord Protector is a single lumen catheter designed to cover the distal end of the Subvalvυlar Chord assembly within the confines of the Access Sheath (reference Figure 3-61).

Figure 3-61: Anterior Chord Protector

The Anterior Chord Protector consists of a distal tip, catheter shaft, marker band, and proximal hub.

The distal tip of the Anterior Chord Protector is a polycarbonate tube 0.275 inches in length. The ID of the rube is 0.129 inches at the proximal end and transitions, 0.15 inches from the proximal end, to an BD of 0.090 inches. The distal end has an outward radius. The proximal end is bonded with ultraviolet adhesive to the catheter shaft.

The catheter shaft is approximately 14 inches in length. The shaft is constructed of a 20% Barium loaded PEBAX rube, reinforced with a stainless steel braid, and lined with an inner ePTFE layer. The ID of the tube is 0.11 inches and the OD is 0.12 inches. A stainless steel marker band, 0.225 inches in length, is bonded with ultraviolet adhesive at the distal tip. A white mark is located in the mid segment of the catheter shaft that indicates the when the distal tip of the Anterior Chord Protector is at the distal tip of the Access Sheath. The proximal portion of the shaft has a polyolefin heat shrink, labeled "ANT."

The proximal portion of the catheter shaft is bonded with ultraviolet adhesive to an ABS female hub connector. The female connector is 0.124 inches long with an ID of 0.120 inches and an OD of 0.255 inches.

3.2.3.4 Sizing and Therapeutic Evaluation

The Sizing and Therapeutic Evaluation phase utilizes a Sizing Instrument, a Cautery Device, and a Cautery Guide (reference Figure 3-62).

Figure 3-62: Sizing and Therapeutic Evaluation Phase Devices

3.2.3.4.1 Sizing Instrument

The Sizing Instrument is similar in design to the Sizing Instrument utilized for the Coapsys device and is used to adjust the Subvalvular Chord to the appropriate length prior to deployment of the staple mechanism within the Anterior Pad (reference Figure 3-63).

Like the Coapsys Sizing Instrument, the iCoapsys Sizing Instrument has a threaded rod assembly at the proximal end inserted through a guide block assembly and a guide tube printed with a graduated scale. A collet assembly, similar to the Coapsys collet assembly, is mechanically fit to the distal end of the rod assembly. The rod and collet assembly slide proximal and distal within the guide tube. The guide block assembly is a polycarbonate spring-loaded component, approximately 0.5 inches long, that stabilizes the rod assembly in the desired location. The collet assembly is bonded with epoxy and threaded into a polycarbonate cone tip that is 0.48 inches in length. The cone tip is bonded with epoxy to an extension tube reinforced with coiled wire. The most notable difference from the sizing device utilized for the Coapsys Device compared to the sizing device utilized for the iCoapsys Device is the extension tube and distal tip of the iCoapsys Sizing Instrument The extension is constructed of a hytrel and polyolefin tube with an internal extension spring. The extension tube is approximately 13 inches long, with an approximate 0.069 inch ID and an approximate 0.125 inch OD. A stainless steel marker band is bonded with ultraviolet adhesive to the distal portion of the tube. A polycarbonate tip, 0.333 inches in length is bonded with ultraviolet adhesive to the distal tip of the tube.

3.2.3.4.2 Cautery Device

The Cautery Device is a high temperature, handheld cutting instrument that is used to trim the Subvalvular Chord once the staple has been deployed in the Anterior Pad. The iCoapsys Cautery Device is identical to the Cautery Device utilized for the surgical Coapsys procedure (reference G020279) with the exception of the specified length (five inches) of the distal shaft necessary to facilitate the percutaneous iCoapsys procedure. Figure 3-64 provides a picture of the iCoapsys Cautery Device with the Coapsys Cautery Device included for reference.

The heating elements, activation, materials, and all other dimensions of the device are identical to the Coapsys Cautery Device.

The Cautery Device is a purchased component from Aaron Medical, Inc. The Coapsys Cautery Device is specified as the Cautery knife and iCoapsys Cautery Device is specified as the 5" Cautery knife. The Coapsys Cautery Device utilized a unique tip design for the heated element. The specified tip materials, length and width of the tip of the iCoapsys Cautery Device are identical to the Coapsys Cautery Device.

3.2.3.4.3 Cautery Guide

The Cautery Guide is a single lumen guide with a handle, designed to facilitate the introduction of the Cautery Device to the appropriate Subvalvular Chord location (reference Figure 3-65).

The Cautery Guide consists of a tip, tube, cap, and handle.

The distal end of the Cautery Guide consists of a tapered PEEK tip 1.13 inches in length. The tip contains a Subvalvular Chord lumen 0.086 inches in diameter along the tapered segment, which transitions to a perpendicular through lumen approximately 0.20 inches from the proximal end of the tip. The proximal end of the tip contains a hollow lumen 0.070 inches in width, 0.170 inches in length, and 0.425 inches deep (into the tip). Note: The hollow lumen is designed to be compatible with the distal tip of the Cautery Device. The outer surface of the tip is bonded with ultraviolet adhesive to a nylon tube.

The nylon tube is approximately four inches in length, with an ID of 0.313 inches and an OD of 0.375 inches. The proximal end of the nylon tube is bonded with ultraviolet adhesive to a cap molded from PEEK material. The cap has one through hole designed to interface with the Cautery Device. A stainless steel hypotube, approximately 5.5 inches in length is bonded with epoxy to the proximal side of the cap. The hypotube has an ED of 0.106 inches and an OD of 0.134 inches. The proximal end of the hypotube is bonded with epoxy to a one inch long PEEK fitting. The hypotυbe and fitting are designed to be the "handle" of the Cautery Guide.

The following picture, Figure 3-66, illustrates the Cautery Device inserted in the Cautery Guide.

33 Procedure

3.3.1 iCoapsys Procedure

Like the Coapsys Device, the iCoapsys Device is placed transventricularly, between a point apical to the right ventricular outflow tract and approximately two centimeters medial to the inter- ventricular groove (anterior position) and a point on the posterior LV wall directly between the papillary muscles and two to three centimeters apical from the mitral valve annυlus, such that the most basal head of the Posterior Pad rests at the level of the annulus (posterior position).

The iCoapsys procedure has been modified from the Coapsys procedure to facilitate percutaneous implant of the device via a subxiphoid approach. Percutaneous implantation of the iCoapsys Device is performed by first entering the mediastinal space of the thoracic cavity through a right xiphoid skin incision. Access to the pericardial space is subsequently gained using interventional instruments provided with the iCoapsys Delivery System and ancillary commercially available devices and equipment. Actual placement of the implant is achieved with the use of specially designed catheters (provided with the iCoapsys System) and with the aid of fluoroscopic (fluoro) and echocardiographic (echo) guidance.

The entire iCoapsys procedure is conducted in four distinct phases: 1) Percutaneous Pericardial Access, 2) Site Identification, 3) Device Implantation, and 4) Sizing and Therapeutic Evaluation. During the Percutaneous Pericardial Access phase, a secure access pathway is created for device delivery from outside the chest wall to inside the pericardial space using fluoroscopic guidance. Optimum locations for the Anterior and Posterior Pads are identified during the Site Identification phase using fluoroscopic and echo guidance. During the Device Implantation phase, a transventricular connection is first created using fluoroscopic guidance, and the iCoapsys Device is then delivered over this connection to the previously identified locations. Finally, the iCoapsys Device is sized during the Sizing and Therapeutic Evaluation phase under transesophageal echo (TEE) guidance, and the device is deployed. A detailed description of each phase is provided in the following sections.

3.3.1.1 Percutaneous Pericardial Access Phase

Once basic pre-operation patient management and preparation has occurred and the general implant location has been determined with fluoro and echo evaluations, a small incision is made in the subxiphoid region with standard, commercially available equipment. The iCoapsys Delivery System 8F Introducer (sheath with obturator inserted) is advanced under fluoroscopic guidance through the incision toward the location of the intended pericardial access site.

Once the 8F Introducer is determined to be in the desired position, the obturator is removed from the sheath. The Pericardial Access Needle is then inserted through the sheath to the pericardium and advanced, under fluoroscopic visualization, until a tactile "pop" is felt. The "pop" is a signal to the physician that the tip of the needle has pierced the pericardium and is now engaged with the pericardium by the "gap" and "stop" on the distal end of the needle. Steady pull-back traction is applied to the device with concomitant injection of contrast media through the Y-connector to verify intrapericardial access.

Once the pericardial space is accessed by the needle, the 0.018" Pericardia] Guidewire is advanced under fluoroscopic visualization into the pericardial space and the Pericardial Access Needle and 8F Introducer are removed. A standard, commercially available, wire exchange tool is utilized to exchange the 0.018" Pericardial Guidewire for a standard 0.035" Guidewire. A standard, commercially available, 1 IF Introducer (minimum 23 cm length) is advanced over the 0.035" Guidewire and dilator removed. A non-compliant, 20- 25mm x 6 cm, commercially available Balloon Catheter, with a minimum rated burst pressure of 4 atm, is advanced through the 1 IF Introducer into the pericardial opening. Upon retraction of the 1 IF Introducer, the Balloon is inflated to dilate the pericardium, mediastinal, and subdeπnal layers and is then removed, with the 0.035" Guidewire left in position. The dilator component of the Access Sheath is advanced over the 0.035" Guidewire, into the pericardial opening for additional dilation of the pericardial access site. The dilator is then retracted, leaving the 0.035" Guidewire in position.

Once the access pathway is dilated, the iCoapsys Delivery System Access Sheath (with dilator) is advanced through the opening until the protruded edge (pericardial securement feature) of the sheath is engaged with the pericardial opening. Figure 3-67 illustrates an in vivo example of the sheath and dilator entering the pericardial space and Figure 3-68 illustrates the sheath (with lip engaged) in the pericardial space.

Figure 3-67: Pericardial Access (in vivo) Figure 3-68: Pericardial Access (model)

The dilator and 0.035" Guidewire are removed once the Access Sheath is secured in location with the securement clamp. This provides entrance to the pericardial space for the rest of the iCoapsys procedure. The Catheter Securement clip is attached to the proximal end of the sheath to aid in stabilization of the Delivery System devices during the subsequent phases. 3.3.1.2 Site Identification Phase

Once access into the pericardial space is secured, AP (relative to the heart) fluoroscopic views and left-sided angiography and RVgrams are used to identify the approximate implant location. The iCoapsys Delivery System Vacuum Tubing Set and Anterior and Posterior Vacuum Lines are connected to an institutional vacuum source. The ICE Delivery Catheter is connected to the Anterior Vacuum Line and a commercially available Acuson Acunav™ Intra Cardiac Echo (ICE) imaging catheter is advanced into the ICE Delivery Catheter.

The ICE Delivery Catheter is inserted to the pericardial space and advanced to the desired Anterior Pad location on the epicardial surface of the heart. The vacuum stabilization cup of the ICE Delivery Catheter is secured by vacuum to the desired epicardial location. This allows short axis echo imaging to confirm anterior position. Adjustments in position are made if necessary. Figures 3-69 and 3-70 illustrate the location of the ICE Delivery Catheter (and ICE imaging catheter) and an example of the short axis image obtained from the ICE imaging catheter. Note: Sheath illustrations in Figure 3-69 is for reference only and does not represent the final design as described previously in this document.

The proximal end of the ICE Delivery Catheter is placed in the anterior clip of the Catheter Securement Clip.

The desired location of the Posterior Pad is identified using an AP (relative to the heart) fluoroscopic view and a left-sided angiogram. The posterior location is identified as approximately the middle of the posterior LV wall and two to three centimeters apical to the left circumflex coronary artery. The Posterior Sighting Catheter is connected with the Posterior Vacuum Line and advanced into the pericardial space to the approximate Posterior Pad location.

The distal cup of the Posterior Sighting Catheter is secured to the epicardial surface of the heart by applying vacuum. The proximal portion of the Posterior Sighting Catheter is placed in the posterior clip of the Catheter Securement Clip (reference Figure 3-71). Using ICE images, fluoroscopic evaluations, and TEE, the distal cup of the Posterior Sighting Catheter is confirmed to be in the desired Posterior Pad location. Adjustments in position are made if necessary.

Figure 3-71: ICE Delivery Catheter and Posterior Sighting Catheter Locations

ICE Delivery Catheter

Next, the fluoroscopy camera is reoriented such that the ICE imaging catheter array is superimposed on the Posterior Sighting Catheter distal cup. The location of the ICE Delivery Catheter is noted on fluoroscopy and is then replaced with the Anterior Sighting Catheter (reference Figures 3-72 and 3-73) such that the inner solid marker (ball) features of each of the Anterior and Posterior Sighting Catheters are superimposed upon each other (reference Figures 3-74 and 3-75). Note: Sheath illustrations in the following figures are for reference only and do not represent the final design as described previously in this document

Figure 3-72: Apical View of Alignment with Figure 3-73: Apical View of Alignment with ICE Delivery Catheter Anterior Sighting Catheter

Position of the distal cup of the Anterior Sighting Catheter is stabilized by applying vacuum to the catheter. The proximal portion of the Anterior Sighting Catheter is placed in the anterior clip of the Catheter Securement Clip (reference Figure 3-76). Figure 3-76: Posterior and Anterior Sighting Catheter Locations

3.3.1.3 Device Implantation Phase

The device implantation phase is conducted under fluoroscopic visualization. In order to ensure the proper orientation of the needle lumen trajectories of the Anterior and Posterior Sighting Catheters in relation to each other, the ball and outer ring marker (sighting rings) within the posterior and anterior distal cups are aligned under fluoroscopic visualization. This is accomplished by effectively "aiming" one catheter at the other by aligning the ball within the sighting ring through manipulation of the distal needle lumen steering mechanisms of each catheter. The following picture, Figure 3-77, illustrates the needle lumen trajectories prior to adjustment of the needle lumen steering mechanisms of the Anterior and Posterior Sighting Catheters. Figure 3-77: Needle Lumen Trajectories Prior to Needle Lumen Steering Mechanism Adjustments

The needle lumen steering mechanism is adjusted on the Anterior Sighting Catheter such that the inner solid marker is centered in the outer ring marker of the distal cup when visualized under fluoroscopic evaluation. This indicates that the needle lumen of the Anterior Sighting Catheter is directed at the Posterior Sighting Catheter distal cup. Figures 3-78 and 3-78 illustrate the inner solid marker and outer ring marker pre and post adjustment.

Once the outer ring marker is centered around the inner solid marker, the needle lumen of the Anterior Sighting Catheter is "aimed" toward the Posterior Sighting Catheter (reference Figure 3-80).

Figure 3-80: Anterior Sighting Catheter Needle Lumen Trajectory Orientated Toward Posterior Sighting Catheter

The needle lumen control mechanism is adjusted on the Posterior Sighting Catheter such that the inner solid marker is centered in the outer ring marker of the distal cup when visualized under fluoroscopic evaluation. Figures 3-81 and 3-82 illustrate the inner solid marker and outer ring marker pre and post adjustment.

Once the outer ring marker is centered around the inner solid marker, the needle lumen of the Posterior Sighting Catheter is "aimed" toward the Anterior Sighting Catheter (reference Figure 3-83).

Figure 3-83: Needle Lumen Trajectories Post Needle Lumen

Once proper positioning and alignment of the needle lumens of the Anterior and Posterior Sighting Catheters are achieved, and confirmed via fluoroscopic visualization, the Anterior Needle is advanced through the needle lumen of the Anterior Sighting Catheter. The Anterior Needle is advanced through the myocardium and into the left ventricle under fluoroscopic guidance. Markers on the Anterior Needle tube are utilized to assure that it is advanced the appropriate distance. The Anterior Needle stylet is removed, leaving the Anterior Needle rube in the left ventricle. The Snare is advanced through the needle rube of the Anterior Needle and deployed in the left ventricle.

The Posterior Needle is advanced through the needle lumen of the Posterior Sighting Catheter, through the myocardium and into the left ventricle under fluoroscopic guidance. Once the Posterior Needle is located in the left ventricle it is then advanced into the Snare device. Markers on the Posterior Needle tube are utilized to aid in identification of the appropriate insertion distance. Figure 3-84 illustrates the Anterior and Posterior Sighting Catheters with the Snare and Posterior Needle.

Figure 3-84: Snare and Posterior Needle Deployed in Left Ventricular Space

Once the Posterior Needle is confirmed to be positioned within the Snare, the Snare is collapsed and the Posterior Needle is captured. The Posterior Needle stylet is removed, leaving the needle tube in place. The Snare is then further collapsed and pulled back into the Anterior Sighting Catheter, drawing the Posterior Needle rube into the needle lumen of the Anterior Sighting Catheter. The Anterior Sighting Catheter is then removed from the patient and the Posterior Sighting Catheter is removed from the patient, leaving the Posterior Needle rube in place.

The posterior side of the needle tube is identified by the white marks. The posterior side is placed in the posterior clip of the Catheter Securement Clip. The anterior side of the needle tube does not contain white marks and is placed in the anterior clip of the Catheter Securement Clip. With the needle tube in place, a lumen across the left ventricle is established through which the Subvalvυlar Chord can be delivered (reference Figure 3-85).

Figure 3-85: Needle Tube Through Left Ventricle of Heart

The Anterior Chord Protector is advanced over the anterior side of the needle tube and placed in the anterior clip of the Catheter Securement Clip.

The leader wire of the Subvalvυlar Chord is passed into the posterior side of the needle tube. The Subvalvular Chord is advanced from the posterior side until it is across the LV, while the needle tube/leader wire is drawn from the anterior side. The large o-ring is removed from the insert of the Subvalvular Chord and the insert is placed into the appropriate sized Posterior Pad (which is attached to the Posterior Pad Catheter).

The Posterior Pad is advanced to the desired posterior location by orienting the Posterior Pad along the cardiac long axis and advancing the Posterior Pad Catheter while pulling the Subvalvυlar Chord from the anterior side (reference Figure 3-86). Figure 3-86: Posterior Pad Catheter and Posterior Pad In Position

Once the Posterior Pad is confirmed in location, the proximal portion of the Posterior Pad Catheter is secured in the posterior clip of the Catheter Securement Clip. The orientation of the Posterior Pad is adjusted to ensure proper placement of the apical and basal heads of the Posterior Pad. ICE imaging, TEE, and angiography are used to visualize the necessary adjustments.

The Anterior Chord Protector and the Subvalvular Chord cover are removed from the Subvalvular Chord, exposing the ePTFE surface. The leader wire of the Subvalvυlar Chord is threaded through the Anterior Pad (which is attached to the Anterior Pad Catheter). The Anterior Pad (in its collapsed configuration) is then advanced over the leader wire through the Access Sheath. Upon exiting the Access Sheath, the Anterior Pad is expanded and rotated into the appropriate orientation for deployment. Proper orientation of the Anterior Pad is confirmed via fluoroscopic and TEE evaluations. Once the Anterior Pad is placed in the desired location, the proximal portion of the Anterior Pad Catheter is placed in the anterior clip of the Catheter Securement Clip (reference Figure 3-87).

Figure 3-87: Anterior and Posterior Pads and Catheters In Position

Catheter Handle

The leader wire of the Subvalvular Chord is threaded into the distal tip of the Sizing Instrument until the Sizing Instrument rests atop the Anterior Pad. Note: Sizing Instrument is not shown in Figure 3-87.

3.3.1.4 Sizing and Therapeutic Evaluation Phase

Once the Sizing Instrument is atop the Anterior Pad and all slack has been removed from the Subvalvular Chord, the length measurement on the Sizing Instrument is noted as the 0% level. Utilizing the Sizing Instrument, the implant is then sized by cinching the Subvalvular Chord in 5% increments, which shortens the distance between the Posterior and Anterior Pad.

Once the desired result has been obtained, as confirmed with TEE imaging, the staple is deployed with in the Anterior Pad. At this point, the procedure is no longer reversible and the Sizing Instrument, catheters, and the Access Sheath are removed from the patient, leaving only the Sυbvalvular Chord exiting the incision.

The Cautery Guide is inserted, over the Subvalvular Chord, until it rests atop the Anterior Pad. The Cautery Device is then inserted into the Cautery Guide and activated to sever the Subvalvular Chord from the Anterior Pad. Once severed, the Cautery Guide and Cautery Device are removed from the patient and the small incision is repaired via standard surgical closure techniques.

Claims

Claims:

1. A set of tools for performing a medical procedure, comprising an anterior anchoring member delivery catheter and a posterior anchoring member delivery catheter; an anterior sighting catheter and a posterior sighting catheter; an anterior needle and a posterior needle; and a sizing instrument.

2. The set of tools of claim 1 , further comprising tools for accessing a pericardial space, including an introducer, an access needle, a guidewire, and an access sheath.

3. A method for treating a heart valve, the method comprising the steps of: accessing the pericardial space; identifying an implantation site on a heart; implanting a device on the heart; and sizing the device on the heart.

4. The method of claim 3, wherein the method includes a percutaneous subxiphoid approach.